Preloaded wire for endoluminal device

ABSTRACT

A system may include an endoluminal prosthesis and a guide wire. The prosthesis may include a tubular body including a graft material wall, a proximal end opening, a distal end opening, and a lumen extending longitudinally therein. The prosthesis may include first and second fenestrations in the graft material wall. The first and second fenestrations may be spaced from one another circumferentially about the tubular body. The guide wire may have a first end and a second end both extending from a region proximal of the proximal end opening. The guide wire may enter the proximal end opening, exit the first fenestration, partially traverse an exterior surface of the prosthesis, enter the second fenestration, and exit the proximal end opening. One or more of the fenestrations may include a branch.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/807,333 filed Jul. 23, 2015, which is a divisional of U.S. patentapplication Ser. No. 13/718,915 filed Dec. 18, 2012, now U.S. Pat. No.9,101,455, which claims priority and the benefit of U.S. provisionalPatent Application Ser. No. 61/579,027, filed Dec. 22, 2011, and is acontinuation-in-part of U.S. patent application Ser. No. 13/208,793,filed Aug. 12, 2011, which claims priority and the benefit of U.S.provisional Patent Application Ser. No. 61/373,610, filed Aug. 13, 2010.Each of these applications are incorporated herein by reference in theirentireties.

TECHNICAL FIELD

The present disclosure relates generally to medical devices. Moreparticularly, it relates to an endoluminal prosthesis for implantationwithin a human or animal body for repair of damaged vessels, ducts, orother physiological pathways and systems and methods for delivering suchan endoluminal prosthesis.

BACKGROUND

The deployment of a medical device, such as an endoluminal prosthesis,into the vessel of a patient from a remote location by the use of acatheter delivery device is generally known. A catheter delivery devicecarrying an endoluminal prosthesis is delivered into a vessel over aguide wire previously placed within the vessel. Once the catheter deviceis positioned, the prosthesis is released and expanded to repair thevessel.

An endoluminal prosthesis can be used, for example, to repair diseasedand/or damaged conduits, such as blood vessels, the esophagus, thetrachea, and the like. Over the past decade, endoluminal prostheses havebecome a popular option for treating damage and disease to bloodvessels, such as abdominal aortic and/or thoracic aneurysms.

In some cases, it may be necessary to deploy an endoluminal prosthesisin a major vessel (e.g., the aorta) at or near an intersecting branchvessel (e.g., innominate, carotid, subclavian, celiac, SMA, and renalarteries). In these cases, an endoluminal prosthesis may be providedwith one or more fenestrations so that the prosthesis can overlap thebranch vessels without blocking flow to these vessels. Once theprosthesis is placed in the main vessel, it may be necessary to provideinterventional access between the main vessel and a branch vessel. Forexample, a physician may desire to deliver additional interventionalcatheters carrying balloons, stents, grafts, imaging devices, and thelike through the fenestration.

Before such a catheter device can be delivered through the fenestrationto a target vessel, however, a guide wire must be provided and deliveredthrough the fenestration to the target vessel. Typically, this requiresmultiple steps. First, the physician must deliver and navigate a set ofcatheters and wires to pass a guide wire through the fenestration. Oncethe fenestration is cannulated, the physician must then deliver andnavigate a separate set of catheters and wires to pass a guide wire intothe target vessel. These procedures are labor intensive, involvemanipulating multiple wires in a vessel at the same time, and dependheavily on the skill of the physician to cannulate both the fenestrationand the target vessel. The steps become even more complicated andnumerous when the physician needs to cannulate more than onefenestration and more than one target vessel. In addition, thecomplexity of the procedure increases as the number of cannulating wiresincreases, since the physician must take precaution to ensure that themultiple wire ends do not become entangled, or that they do notinadvertently contact and damage the prosthesis or a vessel wall.

The present disclosure is directed to devices and systems that overcomethese, and other issues involved with cannulating fenestrated devices.In particular, the present disclosure is directed to devices, systems,and methods for delivering and deploying a prosthesis comprising afenestration, where such devices, systems, and methods include aprecannulated fenestration. The precannulated fenestration reduces thepotential number of steps and devices, and decreases the complexity ofperforming endoluminal procedures involving fenestrated prostheticdevices.

SUMMARY

The present embodiments provide an endoluminal prosthesis forimplantation within a human or animal body for repair of damagedvessels, ducts, or other physiological pathways and systems and methodfor delivering such an endoluminal prosthesis.

In one example, a system may include an endoluminal prosthesis and aguide wire. The prosthesis may include a tubular body including a graftmaterial wall, a proximal end opening, a distal end opening, and a lumenextending longitudinally therein. The prosthesis may include a firstfenestration in the graft material wall and a second fenestration in thegraft material wall. The first fenestration and the second fenestrationmay be spaced from one another circumferentially about the tubular body.The guide wire may have a first end and a second end both extending froma region proximal of the proximal end opening. The guide wire may enterthe proximal end opening, exit the first fenestration, partiallytraverse an exterior surface of the prosthesis, enter the secondfenestration, and exit the proximal end opening. No portion of the guidewire may extend distally beyond the distal end opening.

In another example, a system may include an endoluminal prosthesis and aguide wire. The prosthesis may include a tubular body including a graftmaterial wall, a proximal end opening, a distal end opening, and a lumenextending longitudinally therein. The prosthesis may include a firstfenestration in the graft material wall and a second fenestration in thegraft material wall and spaced circumferentially from the firstfenestration. The guide wire may have a first end and a second end bothextending proximal of the proximal end opening. The guide wire may enterthe proximal end opening, exit the first fenestration, partiallytraverse an exterior surface of the prosthesis, enter the secondfenestration, and exit the proximal end opening. A segment of the guidewire extending between the first fenestration and the secondfenestration may be positioned longitudinally between the proximal endopening and the distal end opening of the prosthesis.

In another example, a method of deploying a branch prosthesis in a mainprosthesis may include providing the main prosthesis and a guide wire.The main prosthesis may include a tubular body including a graftmaterial wall, a proximal end opening, a distal end opening, a firstfenestration in the graft material wall, and a second fenestration inthe graft material wall. The guide wire may enter the proximal endopening, exit the first fenestration, partially traverse an exteriorsurface of the prosthesis, enter the second fenestration, and exit theproximal end opening. No portion of the guide wire may extend distallybeyond the distal end opening. The method may include guiding anintroducer over a first end of the guide wire and through the firstfenestration of the prosthesis. The method may include guiding anintroducer over a second end of the guide wire and through the secondfenestration of the prosthesis.

Other systems, methods, features, and advantages of the invention willbe, or will become, apparent to one with skill in the art uponexamination of the following figures and detailed description. It isintended that all such additional systems, methods, features, andadvantages be within the scope of the invention, and be encompassed bythe following claims.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1 depicts one example of a device for delivering and deploying anendoluminal prosthesis.

FIG. 2 depicts a distal portion of one example of a device fordelivering and deploying an endoluminal prosthesis, including oneexample of a prosthesis with a precannulated fenestration.

FIG. 3 depicts a proximal portion of one example of a device fordelivering and deploying an endoluminal prosthesis, including oneexample of a prosthesis with a precannulated fenestration.

FIG. 4 is a cross-sectional view of a distal portion of one example of apusher comprising auxiliary catheters and a precannulating wirestructure.

FIG. 5 is a cross-sectional view of one example of a proximal attachmentregion for a delivery and deployment device.

FIG. 6 is a cross-sectional view of one example of a distal attachmentregion for a delivery and deployment device.

FIGS. 7-12 depict various stages of one example of a method of using adelivery and deployment device including one example of a prosthesiswith precannulated fenestrations.

FIG. 13 illustrates one example of an endoluminal prosthesis and a guidewire received in the prosthesis in one example of a preloadedconfiguration.

FIG. 14 illustrates a close up view of one example of a pivotablefenestration in a concave orientation.

FIG. 15 illustrates a close up view of one example of a pivotablefenestration in a convex orientation.

FIG. 16 illustrates one example of an endoluminal prosthesis and a guidewire received in the prosthesis in one example of a preloadedconfiguration.

FIG. 17 illustrates one example of an endoluminal prosthesis and a guidewire received in the prosthesis in one example of a preloadedconfiguration.

FIG. 18 illustrates the prosthesis of FIG. 17 deployed within anabdominal aorta of a patient.

FIG. 19 illustrates one example of a sheath introduced over a segment ofthe guide wire and into a fenestration of the prosthesis shown in FIG.18.

FIGS. 20-21 illustrate one example of a catheter and a wire guideintroduced within the sheath shown in FIG. 19 and into a renal artery.

FIG. 22 illustrates one example of a sheath introduced over anothersegment of the guide wire and into another fenestration of theprosthesis shown in FIG. 18 and one example of a catheter and a wireguide introduced within the sheath and into another renal artery.

FIG. 23 illustrates one example of introducers advanced within thesheaths shown in FIGS. 19-22.

FIG. 24 illustrates the prosthesis shown in FIG. 18 with exemplarybranch extension prostheses deployed in the fenestrations and branchesof the prosthesis.

FIG. 25 illustrates one example of an endoluminal prosthesis and a guidewire received in the prosthesis in one example of a preloadedconfiguration.

FIG. 26 illustrates one example of a sheath introduced over a segment ofthe guide wire, and through each of a fenestration and two branches ofthe prosthesis shown in FIG. 25.

FIG. 27 illustrates the sheath shown in FIG. 26 retracted out of the twobranches of the prosthesis shown in FIG. 25.

FIG. 28 illustrates the prosthesis of FIG. 25 with one fenestration andone branch cannulated with exemplary wire guides.

FIG. 29 illustrates on example of a sheath introduced over anothersegment of the guide wire, and through each of a fenestration and twobranches of the prosthesis shown in FIG. 25.

FIG. 30 illustrates the sheath shown in FIG. 29 retracted out of the twobranches of the prosthesis shown in FIG. 25.

FIG. 31 illustrates the prosthesis of FIG. 25 with two fenestrations andtwo branches cannulated with exemplary wire guides.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERREDEMBODIMENTS

The present disclosure relates to an endoluminal prosthesis forimplantation within a human or animal body for repair of damagedvessels, ducts, or other physiological pathways and systems and methodsfor delivering such an endoluminal prosthesis.

Throughout the specification, when referring to any portion of anendoluminal prosthesis or a device or system for delivering anendoluminal prosthesis, the terms “proximal” and “proximally” shalldenote a position, direction, or orientation that is generally toward,or in the direction of, the operator of the device or system. The terms“distal” and “distally” shall denote a position, direction, ororientation that is generally toward, or in the direction of, thepatient.

Throughout the specification, unless the context requires otherwise, thewords “comprise,” “include,” “and have,” and variations such as“comprising,” “including,” and “having,” imply the inclusion of an itemor group of items, without the exclusion of any other item or group ofitems.

The term “prosthesis” means any device, object, or structure thatsupports, repairs, or replaces, or is configured to support, repair, orreplace a body part or a function of that body part. The term prosthesisalso can mean a device that enhances or adds functionality to aphysiological system. The term prosthesis may include, for example andwithout limitation, a stent, stent graft, filter, valve, balloon,embolization coil, and the like.

The term “stent” means any device or structure that provides or isconfigured to provide rigidity, expansion force, or support to a bodypart, for example, a diseased, damaged, or otherwise compromised bodylumen. A stent may include any suitable biocompatible material,including, but not limited to fabrics, metals, plastics, and the like.Examples of suitable materials may include metals such as stainlesssteel and nitinol, and plastics such as polyethylene terephthalate(PET), polytetrafluoroethylene (PTFE), and polyurethane.

A stent may be “expandable,” that is, it may be capable of beingexpanded to a larger-dimension configuration. A stent may expand byvirtue of its own resilience (i.e., self-expanding), upon theapplication of an external force (i.e., balloon-expandable), or by acombination of both. In one example, a stent may have one or moreself-expanding portions and one or more balloon-expandable portions. Anexample of a suitable self-expanding stent includes Z-STENTS®, which areavailable from Cook Medial Incorporated, Bloomington, Ind., USA.

The term “graft” describes an object, device, or structure that isjoined or that is capable of being joined to a body part to enhance,repair, or replace a portion or a function of that body part. Graftsthat can be used to repair body vessels may include, for example, films,coatings, or sheets of material that are formed or adapted to conform tothe body vessel that is being enhanced, repaired, or replaced. A stentmay be attached to or associated with a graft to form a “stent graft.”

A graft material may include a biocompatible synthetic or biologicalmaterial. Examples of suitable synthetic materials may include fabrics,woven and non-woven materials, and porous and non-porous sheetmaterials. One exemplary synthetic graft material includes a wovenpolyester having a twill weave and a porosity of about 350 ml/min/cm²,and is available from VASCUTEK® Ltd., Renfrewshire, Scotland, UK. Othersynthetic graft materials may include biocompatible materials such aspolyester, polytetrafluoroethylene (PTFE), polyurethane, and the like.Examples of suitable biological materials may include, for example,pericardial tissue and extracellular matrix materials such as SIS.

Examples of suitable graft materials are described in U.S. Pat. Nos.4,502,159, 4,675,361, 4,861,830, 4,902,508, 5,017,664, 5,733,337,6,206,931, 6,358,284, 6,379,710, 6,666,892, 6,752,826, and 6,939,377, inU.S. Patent Application Publication Nos. 2002/0187288 and 2003/0149471,and in International Patent Application Publication No. WO 98/22158,each of which is incorporated by reference herein in its entirety.

The term “vessel” refers to a tube, cavity, duct, or canal in whichfluid may be contained, conveyed, and/or circulated. A body vessel (asopposed to a prosthetic vessel) is a vessel that exists naturally, or isformed naturally in the body. Examples of body vessels may include, butare not limited to, blood vessels such as the aorta and the femoralartery, the esophagus, the trachea, the ureter, the bile duct, and thelike. Examples of prosthetic vessels may include, but are not limitedto, stents, grafts, stent grafts, venous or aortal valves, vena cavafilters, and the like.

The term “lumen” describes a space within a vessel in which fluid may becontained, conveyed, and/or circulated. The term “endoluminal” meanswithin a lumen, and can refer to objects that are found or that can beplaced within a lumen, or methods or processes that occur within alumen. An “endoluminal prosthesis” is a prosthesis that is found or thatcan be placed within a lumen. Examples of endoluminal prostheses mayinclude, but are not limited to, stents, grafts, stent grafts, venous oraortal valves, vena cava filters, and the like. An endoluminalprosthesis may be generally tubular and include one or more lumens.Examples of tubular prostheses may include, but are not limited to,straight, curved, branched, and bifurcated prostheses.

The term “fenestration” refers to an opening provided through a surfaceof a prosthesis from the interior of the prosthesis to the exterior ofthe prosthesis. A fenestration may have any suitable geometry including,for example, circular, semi-circular, oval, oblong, or any other shape.

FIG. 1 shows a device for delivering and deploying an endoluminalprosthesis 20 in a vessel of a patient. The device includes a deliverycatheter 1 comprising an external manipulation section 3, a proximalpositioning mechanism or attachment region 5, and a distal positioningmechanism or attachment region 7. The proximal and distal attachmentregions 5, 7 are positioned inside the patient's body during a medicalprocedure, whereas the external manipulation section 3 is positionedoutside the patient's body. During a procedure, the operator controls ormanipulates the external manipulation section 3 to position the proximaland distal attachment regions 5, 7 and to release the prosthesis 20 intothe vessel.

The delivery and deployment device includes an endoluminal prosthesis 20disposed at a distal end portion of the delivery catheter 1 between theproximal and distal attachment regions 5, 7. The prosthesis 20 maycomprise a tubular graft material 18, as described above. The prosthesis20 may additionally or alternatively comprise one or more expandablestents 19 disposed at least partly coextensive with the graft material18. Each stent 19 may be coupled to an interior and/or an exteriorsurface of the graft material 18. The prosthesis 20 shown in FIG. 1comprises a graft material 18 and a plurality of expandable stents 19disposed coextensive with the graft material 18. In addition, theprosthesis 20 shown in FIG. 1 includes a stent 21 extending from thedistal end of the graft material 18 so that it is at least partiallyuncovered from the graft material 18. The bare stent 21 expands andengages the body lumen, thereby anchoring the prosthesis 20 andpreventing the prosthesis from moving after implantation. The stent 21may comprise anchoring means such as, for example, barbs (not shown)that are configured to grasp the walls of the body lumen.

The prosthesis 20 shown in FIG. 1 further comprises a fenestration 27disposed in the graft material between proximal and distal end openingsof the tubular graft 18. The fenestration 27 provides a fluid pathwaythrough the side wall of the graft tube and allows the prosthesis 20 tobe placed in a main vessel in overlapping relationship with anintersecting branch vessel, without interrupting flow to the branchvessel.

The prosthesis 20 is disposed at a distal end portion of the deliverycatheter 1. The prosthesis 20 is retained over the delivery catheter 1by an elongate sheath 30. The sheath 30 comprises an elongate tubularbody having an axial lumen (not shown). The sheath 30 extends proximallyto the manipulation region 3. The prosthesis 20 is disposed within anaxial lumen of the sheath 30 in a radially-compressed configuration. InFIG. 1, the prosthesis 20 is depicted in a partially deployed state,whereby the sheath 30 is partially retracted over the prosthesis,exposing the prosthesis and allowing it to radially expand.

The sheath 30 preferably comprises a flexible structure that is able tobend and flex to negotiate complex and tortuous inner body lumina. Thesheath 30 may comprise a biocompatible plastic such as PTFE,polyethylene, nylon, or the like. Examples of suitable sheath devicesand materials are disclosed in U.S. Pat. Nos. 5,380,304, 6,589,227, and7,025,758, and in U.S. Patent Application Publication Nos. 2001/0034514,2002/0032408 and 2006/01555302, each of which is incorporated herein byreference in its entirety.

The delivery catheter shown in FIG. 1 further comprises an inner cannula15 that extends distally from the manipulation region 3 to the distalattachment region 7. The inner cannula 15 has an axial lumen that isconfigured to receive a guide wire 13. The inner cannula 15 extendsdistally from a proximal end portion of the delivery catheter 1 to adistal end portion of the catheter. A tapered extension 11 is coupled tothe distal end of the cannula 15 and forms the distal end of thedelivery catheter 1. Connection means 16 is coupled to the proximal endof the cannula 15. Connection means 16 is adapted to accept a syringeand may be used to introduce reagents into the body lumen.

The cannula 15 is slidingly disposed within the lumen of the sheath 30.The prosthesis 20 is retained over a distal portion of the cannula 15 bythe sheath 30. The cannula 15 is preferably flexible so that the devicecan be advanced within a relatively tortuous vessel, such as a femoralartery or the aortic arch. The cannula 15 may comprise metal, forexample aluminum, stainless steel, or nitinol. The cannula 15 is inmechanical communication with the flexible extension 11. This allows theoperator to control the flexible extension 11 remotely during aprocedure. For example, the operator can rotate or slide the flexibleextension 11 relative to the prosthesis 20 by manipulating the cannula15.

The delivery catheter 1 shown in FIG. 1 further comprises an elongatetubular pusher 28 that extends distally from the manipulation region 3to the proximal attachment region 5. The cannula 15 is slidably disposedwithin an axial lumen (not shown) of the pusher 28. The sheath 30 isslidably disposed over a distal end portion of the pusher 28. The pusher28 may comprise any suitable biocompatible material including metal orplastic. The pusher 28 may comprise a radiopaque material. Suitablematerials include, but are not limited to aluminum, nitinol, nylon,polypropylene, and polyethylene. The pusher 28 preferably has highlongitudinal column strength to ensure adequate energy transfer betweenthe user and the prosthesis during deployment.

The delivery and deployment device further comprises a haemostaticsealing means 35 for controlling blood loss through the delivery anddeployment device. The sealing means 35 is fixedly connected to thesheath 30 and couples the sheath and the pusher 28. The sealing means 35comprises one or more haemostatic valves (not shown) that provide ahaemostatic seal between the sheath 30 and the pusher 28. Suitablehaemostatic valves include, for example, disk valves, iris valves, andthe like. The haemostatic sealing means 35 also may include a side tube36 that facilitates the introduction of medical reagents between thepusher 28 and the sheath 30. U.S. Pat. Nos. 6,416,499 and 7,651,519, andU.S. Patent Application Publication Nos. 2005/0171479 and 2007/0078395describe examples of suitable haemostatic sealing devices that can beused with a delivery catheter described in the present disclosure. Eachof these patent references is incorporated by reference herein in itsentirety.

The distal end of the pusher 28 is disposed adjacent the proximal end ofthe prosthesis 20. To deploy the prosthesis 20, the operator slides thesheath 30 proximally while applying distal pressure to the pusher 28 inthe user manipulation region 3. The pusher prevents the prosthesis 20from sliding proximally with the sheath 30 when the sheath is withdrawn.As a result, the sheath 30 retracts proximally over the prosthesis 20,exposing the prosthesis, thereby allowing it to expand radiallyoutwardly.

The proximal end of the pusher 28 is connected to an auxiliary accessdevice 38. The access device 38 comprises a housing 40, a channel 42extending generally axially through the housing, and a port 44 coupledto the channel 42. The port 44 provides fluid and mechanicalcommunication between the user manipulation section 3 and the channel42, which provides fluid and mechanical communication with an axiallumen 33 of the pusher 28 which, in turn, provides fluid and mechanicalcommunication with the prosthesis 20.

FIG. 3 depicts an exemplary access device 38 with multiple channels 42A,42B in communication with multiple ports 44A, 44B. The ports 44A, 44Bmay be used, for example, to introduce medical reagents to theprosthesis through the pusher 28. Alternatively or additionally, theports 44A, 44B may be used to introduce auxiliary medical devices suchas guide wires or interventional catheters to the prosthesis through thepusher 28.

The access device 38 preferably includes one or more haemostatic valves(not shown), as described above, to control blood loss during aprocedure. For example, one or more ports 44A, 44B may comprise one ormore disk valves, iris valves, or the like. Alternatively oradditionally one or more such valves may be placed within the channel 42to control blood loss through the access device 38.

FIGS. 1-4 depict delivery and deployment devices comprising a prosthesis20 with at least one precannulated fenestration 27. The devices comprisea wire 31 having a first end 31A, a second end 31B, and a body portionor intermediate segment 31C disposed between the ends. The wire 31 maybe formed from any suitable material, such as a biocompatible metal orplastic, and with dimensions suitable for the particular application. Inone example, a wire comprises a highly elastic metal, such as nitinol orthe like, and has a diameter in the range of about 0.016 to about 0.018inches. Wires made of other materials, and having other diameters arealso contemplated. Although the delivery catheter 1 is described inconnection with delivery of the prosthesis 20 with the wire 31 preloadedtherein, the delivery catheter is equally suitable for use with otherprostheses (e.g., the prosthesis 100 and/or the prosthesis 200) andwires in other configurations (e.g., the guide wire 150 preloaded in theprostheses 100 as shown in FIG. 13 or the guide wire 150 preloaded inthe prosthesis 200 as shown in FIG. 16-17 or 25).

The wire 31 traverses the delivery catheter 1 between proximal anddistal end portions of the catheter. Each wire end 31A, 31B is disposedat the external manipulation section 3 of the delivery catheter 1 andcan be directly manipulated by the operator during a procedure. The wire31 extends distally from the first end 31A through the port 44A, throughthe axial lumen 33 (shown, for example, in FIG. 3) of the deliverycatheter, into the lumen of the prosthesis 20 (shown, for example, inFIG. 2), and through the fenestration 27, 27A to the exterior of thegraft 18 (shown, for example, in FIGS. 1 and 2). The wire 31 thenextends proximally through the lumen of the prosthesis 20, through theaxial lumen 33 (shown, for example, in FIG. 3), and through the port 44Btoward the second wire end 31B.

In some examples, the lumen 33 may comprise a single lumen structure,and the wire 31 will extend proximally and distally along the deliverycatheter through the single lumen structure. In other examples, thelumen 33 may comprise a multi-lumen structure, and the wire 31 willextend proximally and distally along the delivery catheter throughseparate lumen structures.

The wire 31 is slidably disposed within the fenestration 27, 27A.Consequently, the operator can move the wire 31 proximally through thefenestration 27, 27A by pulling proximally on the first wire end 31A orby pushing distally on the second wire end 31B. Similarly, the operatorcan move the wire 31 distally through the fenestration 27, 27A bypulling proximally on the second wire end 31B or by pushing distally onthe first wire end 31A. This feature provides the operator with controlover the positioning and configuration of the wire 31 with respect tothe fenestration 27, 27A. For example, it may be possible to manipulatethe angle of the wire 31 as it passes through the fenestration 27, 27Aby fixing the position of the first wire end 31A and manipulating thesecond wire end 31B, or vice versa. Other advantages of this featurewill be apparent to one of ordinary skill in the art.

FIG. 2 depicts a prosthesis 20 with multiple (more than one)precannulated fenestrations 27A, 27B. The wire 31 extends distally fromthe first wire end 31A through the axial lumen 33 of the deliverycatheter, into the lumen of the prosthesis 20, and through thefenestration 27A to the exterior of the graft 18. The wire 31 extendsproximally from the exterior of the graft 18 through the fenestration27B into the lumen of the prosthesis 20, and through the axial lumen 33toward the second wire end 31B. As shown in FIG. 2, one or morestabilizing sutures 46A, 46B may be provided along the prosthesis 20 toattach the wire 31 to the graft material and/or to the stent structure.The sutures 46A, 46B preferably limit lateral movement of the wire, butallow the wire to slide axially through the fenestrations 27A, 27B, asdescribed above.

As shown in FIG. 2, the wire 31 may pass through the lumen of theprosthesis 20 as it traverses the fenestrations 27A, 27B. A segment ofthe wire 31 extending between the fenestrations 27A, 27B may traverse orextend along the exterior surface of the graft 18. In some examples, thewire extends approximately 3 cm or more away from a fenestration andthen passes through the graft material into the lumen of the prosthesis.In other examples, the wire extends approximately 6 cm or less away froma fenestration and then passes through the graft material into the lumenof the prosthesis. In other examples, the wire 31 traverses thefenestrations 27A, 27B without passing through the lumen of theprosthesis 20. In other words, the wire 31 traverses the fenestrations27A, 27B along the exterior of the graft 18. The wire 31 may at leastpartially circumferentially traverse the exterior surface of the graft18 between the fenestrations 27A, 27B. Additionally, or alternatively,the wire 31 may be positioned such that no portion of the wire extendsdistally beyond the distal end of the prosthesis 20.

As shown in FIGS. 2-4, auxiliary catheters 50A, 50B may be provided anddelivered to the prosthesis 20 through the auxiliary access device 38.The auxiliary catheters 50A, 50B may comprise, for example, an elongatesheath 54A, 54B, and an elongate dilator 52A, 52B slidably disposedwithin an axial lumen of the sheath 54A, 54B. The auxiliary catheters50A, 50B also may comprise haemostatic sealing means 56A, 56B, asdescribed above, to limit or prevent blood loss through the auxiliarycatheters. In addition, the catheters 50A, 50B may comprise side tubes58A, 58B for introducing medical reagents through the auxiliarycatheters. The dilators 52A, 52B terminate proximally at connectionmeans 60A, 60B. The connection means 60A, 60B may be configured forintroducing medical reagents through the auxiliary catheters. Theauxiliary catheters 50A, 50B are delivered to the prosthesis over thewire ends 31A, 31B through the lumen 33 of the pusher 28, as describedabove.

The auxiliary catheters 50A, 50B may be used to deliver medical devices,such as guide wires, balloons, stents, stent grafts, imaging devices,and the like, from the user manipulation section 3 to the prosthesis 20.For example, as described in greater detail below, the auxiliarycatheters 50A, 50B may be used to cannulate target vessels through thefenestrations 27A, 27B.

As shown in FIGS. 1, 5, and 6, a device for delivering and deploying aprosthesis may optionally comprise one or more retention devices forretaining at least a portion of the prosthesis. For example, a deliverycatheter 1 may comprise a proximal prosthesis retention device 70 forretaining a proximal end of the prosthesis 20 and a distal prosthesisretention device 80 for retaining a distal end of the prosthesis. FIGS.1 and 5 depict an exemplary proximal prosthesis retention device 70comprising a proximal trigger wire 72. The trigger wire 72 extendsbetween the prosthesis 20 and the external manipulation section 3through an axial lumen 33 of the pusher 28. The trigger wire 72preferably is disposed in an axial lumen separate from the cannulatingwire 31 to prevent entanglement between the wires. A proximal end of thewire 72 is connected to control member 74 (FIG. 1). A distal end of thewire 72 is removably connected to the proximal end of the prosthesis 20(FIG. 5) and limits axial displacement of the prosthesis. The triggerwire 72 can be disconnected from the proximal end of the prosthesis 20by manipulating the control member 74, for example by sliding thecontrol member proximally to pull the wire away from the prosthesis.Clamping screw 75 may be provided to clamp the control member 74 toprevent inadvertent disengagement of the trigger wire 72.

FIGS. 1 and 6 depict an exemplary distal prosthesis retention device 80comprising a distal trigger wire 82 and a top cap 86. The cap 86 isfixedly coupled to the inner cannula 15 and holds the distal end of theprosthesis 20 in a radially constrained configuration. The cap 86prevents the distal end of the prosthesis 20 from expanding during use.The trigger wire 82 extends between the prosthesis 20 and the externalmanipulation section 3 through an axial lumen 33 of the pusher 28. Thetrigger wire 82 preferably is disposed in an axial lumen separate fromthe cannulating wire 31 to prevent entanglement of the wires. A proximalend of the wire 82 is connected to the control member 84 (FIG. 1). Adistal end of the wire 82 is removably connected to the distal end ofthe prosthesis 20 and to the cap 86. The trigger wire 82 can bedisconnected from the prosthesis 20 and the cap 86 by manipulating thecontrol member 84, for example, by sliding the control member proximallyto pull the wire away from the prosthesis and the cap. A clamping screw85 may be provided to clamp the control member 84 to prevent inadvertentdisengagement of the trigger wire 82. Once the wire 82 disengages theprosthesis 20 and the cap 86, the cap can be removed from the prosthesisby sliding the inner cannula 15 distally with respect to the pusher 28.

Various devices and systems for retaining proximal, distal, and medialportions of a prosthesis are disclosed in the patent literature. Forexample, U.S. Pat. Nos. 6,524,335, 7,335,224, 7,435,253, 7,537,606,7,611,529, 7,651,519, and 7,722,657, and U.S. Patent ApplicationPublication Nos. 2004/230287, 2006/0004433, 2007/0043425, and2008/0294234 disclose devices and systems that are suitable for use withthe present invention. Each of these patent references is incorporatedherein by reference in its entirety.

FIGS. 7-12 depict various stages of a method for delivering anddeploying a prosthesis comprising a precannulated fenestration into theaorta. Although the method is described in relation to a device fortreating the aorta, it can readily be applied to other devices andindications.

A delivery catheter 1, as described, for example with respect to FIG. 1,is provided and comprises a pusher 28 and an inner cannula 15 slidinglydisposed within an axial lumen of the pusher. The delivery catheter 1 isslidingly disposed within an axial lumen of the sheath 30. Theprosthesis 20 is disposed over a distal end portion of the deliverycatheter 1 within the axial lumen of sheath 30. A top cap 86 retains adistal end portion of the prosthesis 20 to prevent premature radialexpansion of the distal end of the prosthesis as the sheath 30 isretracted proximally over the delivery catheter 1. Although not shown inFIGS. 7-12, the prosthesis 20 may comprise one or more expandablestents, as described above.

FIG. 7 depicts the delivery and deployment device disposed in anundeployed configuration within a vessel 90 (such as the aorta). Thedevice comprises a prosthesis 20 with multiple fenestrations 27A, 27Bsized and configured to provide fluid communication between the lumen ofthe prosthesis 20 and the branch vessels 92A, 92B (such as renalarteries) after the prosthesis is deployed. Consequently, the prosthesis20 can be placed within the vessel 90 so that it overlaps the branchvessels 92A, 92B without occluding the branch vessels. The prosthesiscomprises precannulated fenestrations 27A, 27B, as described above. Inparticular, a wire 31 is provided having a first end 31A, a second end31B, and a wire body 31C. The wire 31 extends distally from the firstwire end 31A through the axial lumen 33 of the delivery catheter, intothe lumen of the prosthesis 20, and through the fenestration 27A to theexterior of the graft 18. The wire 31 extends proximally from theexterior of the graft 18 through the fenestration 27B into the lumen ofthe prosthesis 20, and through the axial lumen 33 toward the second wireend 31B.

The delivery catheter 1 may be delivered within the vessel 90 in aconventional manner. A guide wire (not shown) is introduced, forexample, into a femoral artery and advanced into the vessel until thetip of the guide wire extends beyond the region in which the prosthesis20 will be placed. The delivery and deployment device is then insertedover the guide wire 13, via the inner cannula 15, into the vessel 90 andpositioned by radiographic techniques generally known in the art.Provision may be made for a separate angiographic catheter (not shown)at the level of the branch vessels 92.

At this stage, the prosthesis 20 is disposed in a compressedconfiguration within the top cap 86 and an axial lumen of the sheath 30.An auxiliary catheter 50A may be provided and inserted over the firstwire end 31A and through the port 44A into an axial lumen of thedelivery catheter 1. Likewise, an auxiliary catheter 50B may be providedand inserted over the second wire end 31B and through port 44B into anaxial lumen of the delivery catheter 1.

The delivery and deployment device is positioned within the vessel byradiographic means so that the prosthesis 20 overlaps the ostia of, andfenestrations 27A, 27B align with, the branch vessels 92A, 92B. Once thedevice is in a proper position, the sheath 30 is retracted to expose theprosthesis 20. This action releases the prosthesis so that it can expandradially toward the vessel walls, as shown in FIG. 8. The top cap 86retains the distal end of the prosthesis 20, however, and prevents itfrom expanding at this stage. The operator may release the distal end ofthe prosthesis 20 at a desired stage by sliding the top cap 86 distallywith respect to the prosthesis.

In FIG. 9, the auxiliary catheter 50A is advanced distally over the wire31 within the lumen of the prosthesis 20 until the distal end of thesheath 54A passes through the fenestration 27A. Similarly, the auxiliarycatheter 50B is advanced distally over the wire 31 within the lumen ofthe prosthesis 20 until the distal end of the sheath 54B passes throughthe fenestration 27B. In FIG. 10, the dilators 52A, 52B of the auxiliarycatheters 50A, 50B have been removed by withdrawing them proximallythrough the sheaths 54A, 54B.

Next, branch guide wires 94A, 94B are provided for cannulating thebranch vessels. As shown in FIG. 11, the branch guide wire 94A isdelivered through the sheath 54A alongside a first end portion of thewire 31, and the branch guide wire 94B is delivered through the sheath54B alongside a second end portion of the wire 31. Branch accesscatheters 96A, 96B are then introduced over the guide wires 94A, 94B,respectively. The access catheters 96A, 96B preferably have steerabledistal end portions that can be used to guide the branch wires 94A, 94Bthrough the fenestrations 27A, 27B and into respective branch vessels92A, 92B. Suitable catheters are commercially available and include, forexample, the Torcon NB® Advantage Catheters available from Cook MedicalIncorporated, Bloomington Ind., USA.

Once the branch vessels are cannulated, the catheters 96A, 96B areremoved by withdrawing them proximally through the sheaths 54A, 54B. Atthis point, the preloaded wire 31 is no longer needed and may be removedby pulling proximally on the first wire end 31A until the second wireend 31B exits the port 44A, or by pulling on the second wire end untilthe first wire end exits the port 44B.

With the guide wires 94A, 94B in place, the operator may now deliver oneor more interventional catheters 98A, 98B (including, for example,catheters carrying balloons, stents, grafts, imaging devices, and thelike) into the branch vessels 92A, 92B through fenestrations 27A, 27B,as shown in FIG. 12.

FIG. 13 illustrates one example of a prosthesis 100. The prosthesis 100may be configured as a stent graft. To that end, the prosthesis 100 mayinclude a tubular body 101 of a biocompatible graft material. Thetubular body 101 may be configured as a tubular main graft body of theprosthesis 100. The biocompatible graft material may form a sidewall ofthe tubular body 101. The prosthesis 100 may have a proximal end 102 anda distal end 103. The tubular body 101 may include a proximal endopening at the proximal end 102 and a distal end opening at the distalend 103. A lumen 104 may extend generally longitudinally within theprosthesis 100. The lumen 104 may extend from the proximal end openingto the distal end opening to permit passage of blood or other body fluidthrough the tubular body from the distal end to the proximal end.

An anterior side of the prosthesis 100 may extend circumferentiallyaround approximately half of the circumference of the tubular body 101of the prosthesis. A posterior side of the prosthesis 100 may extendcircumferentially around approximately the other half of thecircumference of the tubular body 101. The posterior side of theprosthesis 100 may be positioned opposite the anterior side with respectto the circumference of the prosthesis. In other words, a plane may bedefined to include the longitudinal axis of the prosthesis 100. Theanterior side of the prosthesis 100 may be positioned on one side of theplane, and the posterior side of the prosthesis may be positioned on theopposite side of the plane from the anterior side. The anterior side andthe posterior side may cooperatively form the tubular body 101 of theprosthesis 100.

The prosthesis 100 may include one or more stents 105 (see FIG. 14)coupled to the graft material of the tubular body 101. The stents 105may be conventional stents having any configuration known in the art.The stents 105 may be self-expanding or balloon expandable. Preferably,the stents 105 are self-expanding. The stents 105 may be coupled to aninternal surface of the graft material and/or an external surface of thegraft material. The prosthesis 100 may include an attachment mechanismsuch as an attachment stent 106 at either or both ends of theprosthesis. The attachment mechanism may aid in securing the prosthesis100 within the body vessel to prevent migration of the prosthesis withinthe body vessel.

The prosthesis 100 may include one or more fenestrations or openingsformed through the graft material of the prosthesis. For example, theprosthesis 100 may include one or more fenestrations formed in thesidewall of the tubular body 101. Any of the fenestrations describedherein may be configured as any type of opening providing a fluidpathway through the graft material between the lumen 104 of theprosthesis 100 and a point external to the prosthesis. Additionally, oralternatively, any of the fenestrations described herein may beconfigured to receive a branch extension prosthesis to couple theprosthesis 100 to a branch vessel as further described below.Additionally, or alternatively, any of the fenestrations describedherein may be in fluid communication with a branch extending from thetubular body 101 of the prosthesis 100 as further described below.Additionally, or alternatively, any of the fenestrations describedherein may be pivotable or non-pivotable.

In one example, the prosthesis 100 may include a first fenestration 110,a second fenestration 120, a third fenestration 130, and a scallop 140as shown in FIG. 13. The first and second fenestrations 110, 120 may bepivotable fenestrations, while the third fenestration 130 may benon-pivotable. Although the prosthesis 100 is generally described asincluding two pivotable fenestrations 110, 120 and a non-pivotablefenestration 130, the disclosure is not so limited. In other examples,any of the fenestrations may be pivotable or non-pivotable, and suchexamples are within the scope of this disclosure. The first and secondfenestrations 110, 120 may be positioned on the prosthesis 100 to alignwith, for example, the renal arteries. It will be recognized by one ofordinary skill in the art that the prosthesis 100 may include any numberof openings of any type. Also, the openings may be arranged on theprosthesis in any manner. Preferably, the openings may be arranged tocorrespond to a particular position within the anatomy into which theprosthesis is intended to be placed.

The prosthesis 100 illustrated in FIG. 13 may be configured forplacement in an abdominal aorta of a patient. The prosthesis 100 may beconfigured to extend between a point proximal of the renal arteries anda point distal of the renal arteries. To that end, the scallop 140 maybe configured to align with the celiac artery, the third fenestration130 may be configured to align with the superior mesenteric artery, andthe first and second fenestrations 110, 120 may be configured to alignwith the renal arteries. The scallop 140 may be positionedcircumferentially on an anterior point of the prosthesis 100 andlongitudinally near the distal end 103 of the prosthesis. The anteriorpoint of the prosthesis 100 may extend generally longitudinally alongthe tubular body 101 of the prosthesis and may be substantiallycircumferentially centered on the anterior side of the prosthesis. Thethird fenestration 130 may be positioned circumferentially on theanterior point of the prosthesis 100 and longitudinally proximal of thescallop 140. The first and second fenestrations 110, 120 may be spacedfrom one another around the circumference of the prosthesis 100. Forexample the first fenestration 110 may be configured to align with theright renal artery and may be spaced a first circumferential distancefrom the anterior point of the prosthesis 100. The second fenestration120 may be configured to align with the left renal artery and may bespaced a second circumferential distance from the anterior point of theprosthesis 100. The first and second circumferential distances may be ofsubstantially equal lengths in opposite directions relative to theanterior point of the prosthesis 100. Alternatively, the first andsecond circumferential distances may be different from one another, forexample, to correspond to the anatomy of a particular patient. The firstand second fenestrations 110, 120 may be positioned at substantially thesame longitudinal position along the tubular body 101 of the prosthesis100. Alternatively, the first and second fenestrations 110, 120 may beoffset longitudinally with respect to one another, for example, tocorrespond to the anatomy of a particular patient. The first and secondfenestrations 110, 120 may be positioned longitudinally proximal of thethird fenestration 130 and the scallop 140.

The lumen 104 of the prosthesis 100 may be in fluid communication with apoint external to the prosthesis through each of the first and secondfenestrations 110, 120. Each of the first and second fenestrations 110,120 may be configured to receive a branch extension prosthesis to couplethe prosthesis 100 to a branch vessel within the body of the patient.For example, the first fenestration 110 may be configured to receive abranch extension prosthesis to couple the prosthesis 100 to the leftrenal artery, and the second fenestration 120 may be configured toreceive a branch extension prosthesis to couple the prosthesis to theright renal artery as further described below. In one example, the firstand/or second fenestrations 110, 120 may be configured as pivotablefenestrations such as, for example, those described in U.S. PatentApplication Publication No. 2012/0046728, which is incorporated byreference herein in its entirety. To that end, each of the first andsecond fenestrations 110, 120 may be configured to move or pivotrelative to the tubular body 101 of the prosthesis 100 to account forany misalignment between the fenestration and the corresponding branchvessel.

FIG. 14 shows a close-up view of the second fenestration 120, which maybe configured as a pivotable fenestration. In this example, the secondfenestration 120 may include an inner perimeter 122 surrounding thefenestration 120, a band 124 surrounding the inner perimeter 122, and anouter perimeter 126 surrounding the band 124. The outer perimeter 126may have a diameter that is greater than a diameter of the innerperimeter 122. The inner perimeter 122, the band 124, and the outerperimeter 126 may be substantially concentric with one another ifbrought into the same plane, for example, the surface plane of thetubular body 101. The band may have a first diameter that issubstantially the same as the diameter of the inner perimeter 122 and asecond diameter that is substantially the same as the diameter of theouter perimeter 126. The diameter of the band may decrease in adirection away from the exterior surface of the tubular body 101 fromthe outer perimeter 126 to the inner perimeter 122. In this manner, theinner perimeter 122, the band 124, and the outer perimeter 126 may forman extension having a protruding shape, resembling a dome, or afrustoconical cone extending from the surface of the tubular body 101.The second fenestration 120 may be positioned at the peak or top of theextension. The pivotable fenestration may be placed in a concaveorientation or a convex orientation. In the concave orientation, theextension may extend into the lumen 104 of the prosthesis 100 as shownin FIGS. 13-14. In the convex orientation, the extension may extend awayfrom the lumen 104 as shown in FIG. 15. The pivotable fenestration maybe movable between the concave orientation and the convex orientation.Additionally, or alternatively, the pivotable fenestration may be placedin any position between the concave orientation and the convexorientation. For example, the band 124 may be folded, bent, gathered,pleated, or otherwise manipulated such that the second fenestration 120is generally aligned with the surface plane of the prosthesis 100.

The outer perimeter 126 may be affixed to the graft material of thetubular body 101 by any attachment method including suturingcircumferentially about an aperture disposed through the graft material.The band 124 may be sufficiently flexible to permit the secondfenestration 120 to move such that a branch prosthesis disposed in thefenestration may be oriented upwardly, downwardly, laterally,diagonally, and the like relative to the surface of the tubular body 101of the prosthesis 100. In some examples, the band 124 may permit thesecond fenestration 120 to move up to about 180 degrees relative to thesurface plane of the prosthesis 100. Accordingly, the pivotablefenestration may enable the prosthesis 100 to be used in a variety ofpatients due to its ability to adapt to the variance in the positioningof the diseased branch vessels. For example, if a branch vessel is orbecomes offset longitudinally or axially from the pivotablefenestration, the pivotable fenestration may pivot the branch prosthesisin the necessary direction and to the necessary degree to maintain thebranch prosthesis in place in the branch vessel.

The first fenestration 110 may be configured as a pivotable fenestrationas shown in FIG. 15. To that end, the first fenestration 110 may includean inner perimeter 112 surrounding the fenestration 110, a band 114surrounding the inner perimeter 112, and an outer perimeter 116surrounding the band 114. In this example, the first fenestration 110may be configured generally as described above with reference to thesecond fenestration 120.

As shown throughout FIGS. 14-15, imageable markers 128 may be placed atvarious positions on the prosthesis 100 to identify certain aspects ofthe prosthesis and locations of those aspects during implantation of theprosthesis within the vasculature of a patient. The markers 128 may beviewed during and after placement of the prosthesis 100 to facilitatecorrect placement of the first, second, and/or third fenestrations 110,120, 130, the scallop 140, the ends 102, 103 of the prosthesis, and thelike. For example, as shown in FIG. 14, markers 128 may be placed aboutthe circumference of the outer perimeter 126 of the pivotablefenestration. The markers 128 may be, for example, sewn or sutured tothe graft material of the tubular body 101 or woven into the graftmaterial. Additionally, or alternatively, the markers 128 may be placedon the struts of one or more stents 105. For example, radiopaque markertubes may be placed about one or more struts of any of the stents. Themarkers 128 may be formed from any material that may be imaged by way offluoroscopy, 3D imaging, MRI, or the like. For example, one suitablematerial may be gold.

The prosthesis 100 may be sized and shaped for placement within thevasculature of a patient as further described below. The preferred sizeand shape of the prosthesis 100 may depend on the anatomy in which it isto be implanted. Physiological variables, deployment characteristics,and other factors also may contribute to the determination of a propersize and shape of the prosthesis 100. For example, the prosthesis 100may have a size and shape suitable for placement in the abdominal aorta.To that end, the tubular body 101 of the prosthesis 100 may have adiameter, for example, ranging from about 10 mm to about 38 mm,typically from about 19 mm to about 31 mm. The diameter of the tubularbody 101 may be generally constant along the length thereof.Alternatively, the tubular body 101 may be tapered such that thediameter of the tubular body may generally increase or decrease alongthe length thereof. The first and second fenestrations 110, 120 may beconfigured to align with the renal arteries. Accordingly, the first andsecond fenestrations 110, 120 may have a diameter, for example, rangingfrom about 6 mm to about 24 mm, typically from about 6 mm to about 8 mm.The prosthesis 100 may be deployed in combination with various otherprostheses to effectively bridge an aneurysmal portion of thevasculature.

The tubular body and the bands of the pivotable fenestrations may bemade of any material known in the art. The tubular body may be made ofthe same or a different material as the bands of the pivotablefenestrations. Preferably, the tubular body and the bands may be formedfrom a biocompatible material that is substantially non-toxic in the invivo environment of its intended use and substantially unrejected by thepatient's physiological system (i.e., is non-antigenic). For example,the tubular body and/or the bands of the pivotable fenestrations may bemade of an expanded polytetrafluoroethylene (ePTFE),polytetrafluoroethylene (PTFE), silicone, polyurethane, polyimide(nylon), polyethylene, polypropylene, polyaram ids, polyacrylonitrile,cellulose, or another flexible biocompatible material. Additionally, oralternatively, the tubular body and/or the bands of the pivotablefenestrations may be made of known fabric graft materials, e.g., wovenpolyester such as DACRON® from Invista, Wichita, Kans., USA,polyetherurethanes such as THORALON® from Thoratec Corporation,Pleasanton, Calif., USA, or polyethylene such as an ultra-high molecularweight polyethylene (UHMwPE) such as DYNEEMA® from DSM Dyneema LLC,Stanley, N.C., USA. In addition, materials that are not inherentlybiocompatible may be subjected to surface modifications to render thematerials biocompatible. Examples of surface modifications include, forexample, graft polymerization of biocompatible polymers on the surface,coating of the surface with a crosslinked biocompatible polymer,chemical modification with biocompatible functional groups, orimmobilization of a compatibilizing agent such as heparin or otherbiocompatible substances. Thus, any fibrous material having sufficientstrength to survive in the in vivo environment may be used to form atextile graft, provided the final textile is biocompatible.

The tubular body and/or the bands of the pivotable fenestrations mayinclude a bioremodelable material such as reconstituted ornaturally-derived collagenous materials. Suitable remodelable materialsmay be provided by collagenous extracellular matrix (ECM) materialspossessing biotropic properties. For example, suitable collagenousmaterials may include ECM materials such as those comprising submucosa,renal capsule membrane, dermal collagen, dura mater, pericardium, fascialata, serosa, peritoneum or basement membrane layers, including liverbasement membrane. Suitable submucosa materials for these purposes mayinclude, for instance, intestinal submucosa including small intestinalsubmucosa, stomach submucosa, urinary bladder submucosa, and uterinesubmucosa. Collagenous matrices including submucosa (potentially alongwith other associated tissues) useful in the present invention can beobtained by harvesting such tissue sources and delaminating thesubmucosa-containing matrix from smooth muscle layers, mucosal layers,and/or other layers occurring in the tissue source. For additionalinformation as to some of the materials useful in the present invention,and their isolation and treatment, reference can be made, for example,to U.S. Pat. Nos. 4,902,508, 5,554,389, 5,993,844, 6,206,931, and6,099,567. Non-limiting examples of suitable remodelable materials mayinclude SURGISIS® BIODESIGN™ from Cook Medical Incorporated,Bloomington, Ind., USA or the graft prosthesis material described inU.S. Pat. No. 6,206,931 to Cook et al., which is incorporated herein byreference in its entirety. The graft bodies also may be made of any ofthe materials described in U.S. Pat. No. 7,407,509 to Greenberg et al.or U.S. Patent Application Publication No. 2009/0171451 by Kuppurathanamet al., which are incorporated herein by reference in their entirety.

The stents described herein may have any suitable stent pattern known inthe art. One example of a stent pattern is the Z-stent or Gianturcostent design. Each Z-stent may include a series of substantiallystraight segments or struts interconnected by a series of bent segmentsor bends. The bent segments may include acute bends or apices. TheZ-stents are arranged in a zigzag configuration in which the straightsegments are set at angles relative to one another and are connected bythe bent segments. This design provides both significant radial force aswell as longitudinal support. In tortuous anatomy, branches, orfenestrations, it may be preferable to use alternative stents ormodifications to the Z-stent design to avoid stent-to-stent contact.Alternative stents may include, for example, annular or helical stents.Furthermore, in complex anatomical situations, external stents may havethe potential to become intertwined with the wires or other devicesutilized to ensure branch vessel access, sealing, and fixation. Thus, insome instances, it may be desirable to affix some of the stents to theinternal surface of the prosthesis. The stents may be balloonexpandable. Preferably, the stents may be self-expandable. The stentscan maintain the patency of the prosthesis and ensure adequate sealingagainst the surrounding vascular tissue. Stent amplitude, spacing, andstagger may be adjusted for each prosthesis design. Any of the stentsmentioned herein may include barbs and/or other anchoring members tohelp reduce the potential for prosthesis migration.

The stents described herein may be made from any suitable material knownin the art. In one example, the stents may be made from standard medicalgrade stainless steel and soldered using silver standard solder (0lead/0 tin). In other examples, the stents may be made from a metallicmaterial including any type of stainless steel, silver, platinum,palladium, gold, titanium, tantalum, iridium, tungsten, cobalt,chromium, cobalt-chromium alloy 1058, cobalt-based 35N alloy,nickel-based alloy 625, a molybdenum alloy, a molybdenum alloy includingabout 0.4% to about 0.8% of lanthanum oxide (La₂O₃), and anickel-titanium alloy, or other suitable materials known in the art.Additionally, or alternatively, the stents may be made from nitinol orother shape-memory metal. Moreover, the stents may be configured in avariety of ways to provide a suitable intraluminal support structure.For example, one or more stents may be made from a woven wire structure,a laser-cut cannula, individual interconnected rings, or another patternor design.

Returning to FIG. 13, the prosthesis 100 may be provided as part of apreloaded system that includes a guide wire 150. The guide wire 150 mayenable delivery of one or more branch extension prostheses as furtherdescribed below. In some examples, a single guide wire may enabledelivery of a branch extension prosthesis into multiple openings in theprosthesis.

FIG. 13 illustrates one example of the guide wire 150 received withinthe prosthesis 100 in a preloaded configuration. The guide wire 150 mayinclude a first end segment 152 positioned at a first end of the guidewire and a second end segment 154 positioned at a second end of theguide wire opposite the first end. The guide wire 150 also may include abody portion or intermediate segment 156 positioned between the firstend segment 152 and the second end segment 154. The first end segment152 of the guide wire 150 may extend distally from a proximal end of adelivery device (e.g., the delivery catheter 1 described above). Thefirst end segment 152 may enter the lumen 104 through the proximal end102 of the prosthesis 100. The first end segment 152 may extend distallywithin the lumen 104 and exit the tubular body 101 of the prosthesis 100through the first fenestration 110.

The intermediate segment 156 of the guide wire 150 may extend distallyfrom the first end segment 152 and external of the tubular body 101 ofthe prosthesis 100. The intermediate segment 156 may reenter the tubularbody 101 of the prosthesis 100 through a first guide wire opening 160.The first guide wire opening 160 may be configured as an opening throughthe graft material of the tubular body 101. The first guide wire opening160 may be aligned with the first fenestration 110 with respect to thecircumference of the prosthesis 100 and positioned distal of the thirdfenestration 130 with respect to the longitudinal axis of the prosthesisas shown in FIG. 13. In other examples, the first guide wire opening 160may be positioned at any suitable location on the tubular body 101 ofthe prosthesis 100. The lumen 104 of the prosthesis 100 may be in fluidcommunication with a point external of the prosthesis through the firstguide wire opening 160.

A portion of the intermediate segment 156 of the guide wire 150 may bedisposed within the lumen 104 of the prosthesis 100 and extend betweenthe first guide wire opening 160 and a second guide wire opening 162.The second guide wire opening 162 may be configured generally asdescribed above with respect to the first guide wire opening 160. Thesecond guide wire opening 162 may be aligned with the secondfenestration 120 with respect to the circumference of the prosthesis 100and positioned distal of the third fenestration 130 with respect to thelongitudinal axis of the prosthesis. The portion of the intermediatesegment 156 positioned between the first guide wire opening 160 and thesecond guide wire opening 162 may be substantially U-shaped. The openingof the U-shaped portion of the intermediate segment 156 may faceproximally as shown in FIG. 13. One leg of the U-shaped portion of theintermediate segment 156 may extend distally from the first guide wireopening 160, and the other leg may extend proximally to the second guidewire opening 162. The curved portion of the U-shaped portion of theintermediate segment 156 between the two legs may be positioned distalof the third fenestration 130 with respect to the longitudinal axis ofthe prosthesis 100. In one example, the curved portion of the U-shapedportion of the intermediate segment 156 may overlap with the scallop 140as shown in FIG. 13.

The intermediate segment 156 of the guide wire 150 may exit the lumen104 of the prosthesis 100 through the second guide wire opening 162 andextend proximally external of the tubular body 101 of the prosthesis100. The second end segment 154 of the guide wire 150 may extendproximally from the intermediate segment 156 and enter the tubular body101 of the prosthesis 100 through the second fenestration 120. Thesecond end segment 154 of the guide wire 150 may extend proximallywithin the lumen 104 and exit the lumen 104 through the proximal end 102of the prosthesis 100. The second end segment 154 of the guide wire 150may extend proximally to the proximal end of the delivery device. Thefirst end segment 152 of the guide wire 150 may enable introduction of abranch prosthesis into the first fenestration 110 to couple theprosthesis 100 to the left renal artery, and the second end segment 154of the guide wire 150 may enable introduction of a branch extensionprosthesis into the second fenestration 120 to couple the prosthesis tothe right renal artery.

FIGS. 16-17 illustrate another example of an endoluminal prosthesis 200.The prosthesis 200 may be configured as a stent graft and may be similarto the prosthesis 100 except for the differences described below. Forexample, the prosthesis 200 may include a tubular body 201 of abiocompatible graft material. The prosthesis 200 may have a proximal end202, a distal end 203, and a lumen 204 extending generallylongitudinally within the prosthesis to permit passage of blood or otherbody fluid from the distal end to the proximal end. The prosthesis 200may have an anterior side extending circumferentially aroundapproximately half of the circumference of the tubular body 201 and aposterior side positioned opposite the anterior side with respect to thecircumference of the prosthesis. The anterior side and the posteriorside may cooperatively form the tubular body 201 of the prosthesis 200.

The prosthesis 200 may include one or more stents (not shown) coupled tothe graft material. The stents may be conventional stents having anyconfiguration known in the art as described above with respect to thestents 105 of the prosthesis 100. The prosthesis 200 may include anattachment mechanism such as an attachment stent at either or both endsof the prosthesis as described above with respect to the attachmentmechanism 106 of the prosthesis 100.

The prosthesis 200 may include a first fenestration 210 and a secondfenestration 220. The first and second fenestrations 210, 220 may bepivotable fenestrations as described above with reference to the firstand second fenestrations 110, 120 of the prosthesis 100. Although theprosthesis 200 is generally described as including two pivotablefenestrations 210, 220, this disclosure is not so limited. In otherexamples, any of the fenestrations may be pivotable or non-pivotable,and such examples are within the scope of this disclosure. The first andsecond fenestrations 210, 220 may be positioned on the prosthesis 200 toalign with, for example, the renal arteries.

The prosthesis 200 may include a third fenestration 230, and a fourthfenestration 240, as shown in FIGS. 16-17. Each of the thirdfenestration 230 and the fourth fenestration 240 may be configured as abranch. In other words, the prosthesis 200 may include a first branch231 extending outward from the tubular body 201 and in fluidcommunication with the third fenestration 230 and a second branch 241extending outward from the tubular body 201 and in fluid communicationwith the fourth fenestration 240. Although the prosthesis 200 isgenerally described as having four fenestrations 210, 220, 230, 240, twoof which are configured as branches 231, 241, this disclosure is not solimited. It will be recognized by one of ordinary skill in the art thatthe prosthesis 200 may include any number of openings of any type. Forexample, the first branch and/or the second branch may be omitted.Additionally, or alternatively, the openings may be arranged on theprosthesis in any manner. Preferably, the openings may be arranged tocorrespond to a particular position within the anatomy into which theprosthesis is intended to be placed.

The prosthesis 200 illustrated in FIGS. 16-17 may be configured forplacement in an abdominal aorta of a patient. Additionally, oralternatively, the prosthesis 200 may be configured to extend between apoint distal of the renal arteries and a point proximal of the renalarteries. To that end, the first branch 231 may be configured to alignwith the celiac artery, the second branch 241 may be configured to alignwith the superior mesenteric artery, and the first and secondfenestrations 210, 220 may be configured to align with the renalarteries.

The first branch 231 may include a first end 232 adjacent to the thirdfenestration 230, a second end 233, and a lumen 234 extending generallylongitudinally between the first and second ends of the first branch.The first end 232 of the first branch 231 may be attached to the tubularbody 201 of the prosthesis 200 in any conventional manner. In oneexample, the first end 232 of the first branch 231 may be sutured to thegraft material of the tubular body 201. In another example, the firstbranch 231 and the tubular body 201 may be formed as a unitary piece ofgraft material. The lumen 204 of the tubular body 201 may be in fluidcommunication with a point external to the prosthesis 200 through thelumen 234 of the first branch 231. The second branch 241 may include afirst end 241 adjacent to the fourth fenestration 240, a second end 243,and a lumen 244 extending generally longitudinally between the first andsecond ends of the second branch. The first end 242 of the second branch241 may be attached to the tubular body 201 as described above withreference to the first branch 231. The lumen 204 of the tubular body 201may be in fluid communication with a point external to the prosthesis200 through the lumen 244 of the second branch 241.

The first ends 232, 242 of the first and second branches 231, 241,respectively, may be spaced from one another around the circumference ofthe tubular body 201 of the prosthesis 200. In one example, the firstends 232, 242 of the first and second branches 231, 241, respectively,may be disposed between about 0 and about 310 degrees apart relative toone another, and more preferably, about 30 degrees apart. Additionally,or alternatively, the first ends 232, 242 of the first and secondbranches 231, 241, respectively, may be disposed at a predetermineddistance from one another along the longitudinal axis of the tubularbody 201 of the prosthesis 200. The first end 232 may be distal of thefirst end 242 as shown in FIGS. 16-17, or vice versa. Alternatively, thefirst ends 232, 242 may be disposed in close proximity to one anotheralong the longitudinal axis of the tubular body 201.

Each of the first and second branches 231, 241 may be configured toreceive a branch extension prosthesis to couple the branch to a branchvessel within the body of the patient. For example, the first branch 231may be configured to receive a branch extension prosthesis to couple thefirst branch to the celiac artery, and the second branch 241 may beconfigured to receive a branch extension prosthesis to couple the secondbranch to the superior mesenteric artery, as further described below.The first branch 231 and/or the second branch 241 may extend outwardaway from the tubular body 201 of the prosthesis 200. The first branch231 and/or the second branch 241 may extend proximally with respect tothe tubular body 201 as shown in FIGS. 16-17. In other examples, thefirst branch 231 and/or the second branch 241 may extend distally withrespect to the tubular body 201. Alternatively, or additionally, thefirst branch 231 and/or the second branch 241 may extend at leastpartially circumferentially around the tubular body 201. In other words,the first branch 231 and/or the second branch 241 may include a helicalshape. Such a helical shape may facilitate insertion of a component suchas a branch extension prosthesis into the first branch 231 and/or thesecond branch 241. Such a helical shape also may reduce torsion imposedby blood flow at the juncture between the prosthesis 200 and the branchvessels. Various exemplary helical branches that extend from a main bodyof a prosthesis, which may be used in conjunction with the presentembodiments, are provided in U.S. Pat. No. 7,407,509 to Greenberg etal., which is incorporated by reference herein in its entirety.

The first and second fenestrations 210, 220 may be spaced from oneanother around the circumference of the prosthesis 200. For example thefirst fenestration 210 may be configured to align with the left renalartery and may be spaced a first circumferential distance from theanterior point of the prosthesis 200. The second fenestration 220 may beconfigured to align with the right renal artery and may be spaced asecond circumferential distance from the anterior point of theprosthesis 200. The first and second circumferential distances may be ofsubstantially equal lengths in opposite directions relative to theanterior point of the prosthesis 200. Alternatively, the first andsecond circumferential distances may be different from one another, forexample, to correspond to the anatomy of a particular patient. In oneexample, the first and second fenestrations 210, 220 may be disposedbetween about 50 and about 310 degrees apart relative to one another,and more preferably, about 150 degrees apart. The first and secondfenestrations 210, 220 may be positioned at substantially the samelongitudinal position along the tubular body 201 of the prosthesis 200.Alternatively, the first and second fenestrations 210, 220 may be offsetlongitudinally with respect to one another, for example, to correspondto the anatomy of a particular patient. Additionally, or alternatively,the first and second fenestrations 210, 220 may be positionedlongitudinally proximal of the first branch 231 and the second branch241.

The prosthesis 200 may be provided as part of a preloaded system thatincludes the guide wire 150. FIG. 16 illustrates one example of theguide wire 150 received within the prosthesis 200 in a preloadedconfiguration. The first end segment 152 of the guide wire 150 mayextend distally from the proximal end of the delivery device. The firstend segment 152 may enter the lumen 204 through the proximal end 202 ofthe prosthesis 200. The first end segment 152 may extend distally withinthe lumen 204 and exit the tubular body 201 of the prosthesis 200through the first fenestration 210. The intermediate segment 156 of theguide wire 150 may extend distally external of the tubular body 201 andreenter the lumen 204 of the prosthesis 200 through a first guide wireopening 260. The first guide wire opening 260 may be configuredgenerally as described above with reference to the first guide wireopening 160 of the prosthesis 100. The first guide wire opening 260 maybe aligned with the first fenestration 210 with respect to thecircumference of the prosthesis 200 and positioned proximal of the firstand second branches 231, 241 with respect to the longitudinal axis ofthe prosthesis as shown in FIG. 16. In other examples, the first guidewire opening 260 may be positioned at any suitable location on thetubular body 201 of the prosthesis 200. The lumen 204 of the prosthesis200 may be in fluid communication with a point external of theprosthesis through the first guide wire opening 260.

A portion of the intermediate segment 156 of the guide wire 150 may bedisposed within the lumen 204 of the prosthesis 200 and extend betweenthe first guide wire opening 260 and a second guide wire opening 262.The second guide wire opening 262 may be configured generally asdescribed above with reference to the first guide wire opening 160 ofthe prosthesis 100. The second guide wire opening 262 may be alignedwith the second fenestration 220 with respect to the circumference ofthe prosthesis 200 and positioned proximal of the first and secondbranches 231, 241 with respect to the longitudinal axis of theprosthesis.

The intermediate segment 156 of the guide wire 150 may exit the lumen204 of the prosthesis 200 through the second guide wire opening 262 andextend proximally external of the tubular body 201 of the prosthesis200. The second end segment 154 of the guide wire 150 may enter thetubular body 201 of the prosthesis 200 through the second fenestration220. The second end segment 154 of the guide wire 150 may extendproximally within the lumen 204 and exit the lumen 204 through theproximal end 202 of the prosthesis 200. The second end segment 154 ofthe guide wire 150 may extend proximally to the proximal end of thedelivery device. The first end segment 152 of the guide wire 150 mayenable introduction of a branch prosthesis into the first fenestration210 to couple the prosthesis 200 to the left renal artery, and thesecond end segment 154 of the guide wire 150 may enable introduction ofa branch extension prosthesis into the second fenestration 220 to couplethe prosthesis to the right renal artery. Additionally, oralternatively, the guide wire 150 may be positioned such that no portionof the guide wire extends distally beyond the distal end 203 of theprosthesis 200.

In each of the examples illustrated in FIGS. 13 and 16, the guide wire150 may extend through a guide wire opening (e.g., the first and secondguide wire openings 160, 162 of the prosthesis 100 or the first andsecond guide wire openings 260, 262 of the prosthesis 200). When theguide wire 150 is removed following deployment of the prosthesis withina body vessel, the guide wire openings may remain as holes in the graftmaterial of the prosthesis. If the holes are positioned within ananeurysmal portion 669 (or another damaged portion) of the body vessel,as shown in FIG. 16, blood or other body fluid may leak through theholes in the graft material and into the aneurysmal portion of the bodyvessel. In other words, the guide wire openings in the prosthesis maylead to an endoleak into the aneurysmal portion 669 of the body vessel.Such leakage may cause further damage to the body vessel. Thus, it maybe desirable to provide a prosthesis that is free of guide wireopenings. In other words, it may be desirable to provide a guide wire ina preloaded configuration in which the guide wire does not extendthrough guide wire openings in the tubular body of the prosthesis.

FIG. 17 illustrates another example of the guide wire 150 receivedwithin the prosthesis 200 in a preloaded configuration. In this example,the prosthesis 200 may be substantially free of guide wire openings. Inother words, the prosthesis 200 may not include the first and secondguide wire openings 260, 262 as described above with reference to FIG.16. The first end segment 152 of the guide wire 150 may extend distallyfrom the proximal end of the delivery device. The first end segment 152may enter the lumen 204 through the proximal end 202 of the prosthesis200. The first end segment 152 may extend distally within the lumen 204and exit the tubular body 201 of the prosthesis 200 through the firstfenestration 210.

The intermediate segment 156 of the guide wire 150 may extend betweenthe first fenestration 210 and the second fenestration 220 of theprosthesis 200. The intermediate segment 156 may be disposed on theexterior surface of the tubular body 201 of the prosthesis 200. Theintermediate segment 156 may be substantially U-shaped with the openingof the U-shaped intermediate segment facing proximally as shown in FIG.17. One leg of the U-shaped intermediate segment 156 may extend distallyfrom the first fenestration 210, and the other leg may extend proximallyto the second fenestration 220. The curved portion of the U-shapedintermediate segment 156 may be positioned longitudinally proximal ofthe first and second branches 231, 241 as shown in FIG. 17. In thismanner, the intermediate segment 156 may extend at least partiallycircumferentially around the exterior surface of the tubular body 201 ofthe prosthesis 200. The curve of the U-shaped intermediate segment 156may be positioned between the first and second fenestrations 210, 220and the first and second branches 230, 240 with respect to thelongitudinal axis of the prosthesis 200. In other words, theintermediate segment 156 of the guide wire 150 may be positioned justdistal of the first and second fenestrations 210, 220 of the prosthesis200 as shown in FIG. 17. In other examples, the curved portion of theU-shaped intermediate segment 156 may be positioned longitudinally atany suitable position on the tubular body 201 of the prosthesis 200. Forexample, the legs of the U-shaped intermediate segment 156 may have asufficient length such that the curved portion may be positioned distalof the first and/or second branches 231, 241.

The second end segment 154 of the guide wire 150 may enter the tubularbody 201 of the prosthesis 200 through the second fenestration 220. Thesecond end segment 154 may extend proximally within the lumen 204 andexit the lumen 204 through the proximal end 202 of the prosthesis 200.The second end segment 154 of the guide wire 150 may extend proximallyto the proximal end of the delivery device. The first end segment 152 ofthe guide wire 150 may enable introduction of a branch prosthesis intothe first fenestration 210 to couple the prosthesis 200 to the leftrenal artery, and the second end segment 154 of the guide wire 150 mayenable introduction of a branch prosthesis into the second fenestration220 to couple the prosthesis to the right renal artery. Additionally, oralternatively, the guide wire 150 may be positioned such that no portionof the guide wire extends distally beyond the distal end 203 of theprosthesis 200.

The intermediate segment 156 of the guide wire 150 may extend at leastpartially circumferentially around the anterior side of the prosthesis,the posterior side of the prosthesis, or both the anterior and posteriorsides of the prosthesis. Preferably, the intermediate segment 156 of theguide wire 150 may be disposed on the anterior side of the prosthesisbetween the first and second fenestrations 210, 220 as shown in FIG. 17.This configuration may reduce the length of the guide wire 150 which maybe disposed on the exterior surface of the tubular body 201 of theprosthesis 200. Such a reduced length of the guide wire 150 which may beexposed outside of the prosthesis 200 may reduce the potential ofcatching or snagging the guide wire 150 on components of the deliverysystem which may be used to deploy the prosthesis within the bodyvessel. Such a reduced length also may enable a physician to control thediameter of the prosthesis 200 (e.g., by applying tension to the guidewire 150) as further described below. Additionally, or alternatively,this configuration may enable adjustment of the circumferentialpositions of the first and second fenestrations 210, 220 also as furtherdescribed below.

The intermediate segment 156 of the guide wire 150 may be attached tothe tubular body 201 of the prosthesis 200. The intermediate segment 156may be attached to the prosthesis 200 using any suitable attachmentmechanism. For example, the intermediate segment 156 may be releasablyattached to the exterior surface of the tubular body 201 by one or moresutures 158 as shown in FIG. 17. The sutures 158 may be stitched intothe graft material of the tubular body 201 of the prosthesis 200, andthe guide wire 150 may be received between each suture and the exteriorsurface of the tubular body. In this example, the guide wire 150 may beremoved from the prosthesis 200 by sliding the guide wire out ofengagement with the sutures 158. In another example, the intermediatesegment 156 of the guide wire 150 may be stitched in and out of thegraft material of the tubular body 201. In yet another example, theintermediate segment 156 may be attached to the exterior surface of theprosthesis 200 by a releasable adhesive. In another example, theintermediate segment 156 may be received within a pocket, which may beattached to the exterior surface of the prosthesis 200. The pocket mayinclude a piece of graft material that is folded or rolled to create aninterior passage to receive the intermediate segment 156. The pocket maybe integral with or separate from the tubular body 201 of the prosthesis200. Alternatively, or additionally, the pocket may include a tube orcatheter, which may be attached to the exterior surface of the graftmaterial. The pocket may be positioned radially between the graftmaterial of the tubular body 201 and an external stent of the prosthesis200. In other words, the pocket may be sandwiched between the graftmaterial and the stent. Alternatively, or additionally, the stent mayinclude an aperture configured to receive the pocket and/or theintermediate segment 156 of the guide wire 150.

FIGS. 18-24 illustrate a method of using the prosthesis 200 of FIG. 17to treat a condition (e.g., an aneurysm) in the area of an abdominalaorta and/or branch vessels of a patient. In a first step, theprosthesis 200 may be provided with the guide wire 150 coupled to theprosthesis in the preloaded configuration as shown in FIG. 17. Theprosthesis 200 may be compressed into a delivery state and deliveredinto an abdominal aorta 660 of a patient using any suitable deploymentsystem or introducer (e.g., the delivery catheter 1 described above withreference to FIGS. 1-12). Additionally, or alternatively, an introducersuch as that described in International Patent Application PublicationNo. WO98/53761, entitled “A Prosthesis and a Method and Means ofDeploying a Prosthesis,” which is incorporated herein by reference inits entirety, may be used to deploy the prosthesis 200. WO98/53761describes a deployment system for an endoluminal prosthesis whereby theprosthesis may be radially compressed onto a delivery catheter andcovered by an outer sheath. To deploy the prosthesis, the operator mayslide or retract the outer sheath over the delivery catheter, therebyexposing the prosthesis. The prosthesis may expand outwardly uponremoval of the sheath. The operator may directly manipulate the sheathand the delivery catheter, which may provide the operator with arelatively high degree of control during the procedure. Further, suchdelivery devices may be compact and may have a relatively uniform,low-diameter radial profile, which may enable atraumatic access anddelivery.

Using a suitable introducer, a physician may obtain access to theabdominal aorta 660 via a femoral cut-down with the prosthesis 200 inthe compressed state. The prosthesis 200 may be positioned within theabdominal aorta 660 in the compressed state, for example, using theradiopaque markers 128, such that the first and second branches 231, 241may be generally aligned in the vicinity of the ostia of the celiacartery 662 and the superior mesenteric artery 664, respectively, asshown in FIG. 18. Additionally, the first and second fenestrations 210,220 may be generally aligned in the vicinity of the ostia of the leftrenal artery 666 and the right renal artery 668, respectively, as shownin FIG. 18. At this time, the sheath of the introducer that constrainsthe prosthesis 200 may be retracted proximally relative to the deliverycatheter to enable the prosthesis to expand to the deployedconfiguration shown in FIG. 18.

It should be noted that, in FIGS. 18-24, outer surfaces of theprosthesis 200 are shown as being spaced from inner surfaces of theabdominal aorta 660 solely for illustrative purposes. In use, theprosthesis 200 may be sized and configured so that at least a portion ofthe outer surface of the tubular body 201 securely engages at least aportion of the inner surface of the abdominal aorta 660 to hold theprosthesis 200 in place relative to the vasculature. Optionally,additional modular prostheses may be coupled to the prosthesis 200(e.g., extending into one or more of the iliac arteries), and themodular prostheses may include outer surfaces dimensioned to securelyengage inner surfaces of the iliac arteries or other vasculature.

With the prosthesis 200 positioned within the abdominal aorta 660,tension may be applied to the guide wire 150 to manipulate theprosthesis 200. For example, tension may be applied to the first endsegment 152 and/or the second end segment 154 of the guide wire from theproximal end of the introducer. This may cause a reduction in thecircumference of a portion of the tubular body 201 of the prosthesis 200near the intermediate segment 156 of the guide wire 150 and/or the firstand second fenestrations 210, 220. In other words, the tension on theguide wire 150 may cause the graft material of the tubular body 201 tobe gathered, bunched, pleated, or otherwise manipulated such that aportion of the tubular body may at least partially collapse. This maycreate space between the prosthesis 200 and the inner surface of theabdominal aorta 660, which may enable further manipulation orpositioning of the prosthesis 200 within the body vessel. With theintermediate segment 156 of the guide wire 150 positioned on theanterior side of the prosthesis 200, as shown in FIG. 18, such tensionalso may cause the fenestrations 210, 220 to be pulled closer to oneanother along the circumference of the prosthesis 200 in an anteriordirection. This may aid the physician in aligning the first and secondfenestrations 210, 220 with the left and right renal arteries 666, 668,respectively, which may be positioned on an anterior portion of theabdominal aorta 660. In other examples, the intermediate segment 156 maybe positioned on the posterior side of the prosthesis 200. In theseexamples, tension on the guide wire 150 may cause the fenestrations 210,220 to be pulled closer to one another along the circumference of theprosthesis 200 in a posterior direction.

In a next step, a sheath may be guided over the first end segment 152 ofthe guide wire 150 and through the first fenestration 210. For example,a sheath 670 may be advanced over the first end segment 152 of the guidewire 150 in a distal direction as shown in FIG. 19. The sheath 670 maybe configured as described above with reference to the catheters 50A,50B. To that end, the sheath 670 may include a sheath and a dilator asshown in FIG. 2. The sheath 670 may be advanced distally through thelumen 204 of the prosthesis 200 and out through the first fenestration210 as shown in FIG. 19. A dilator (not shown) may be positioned withinthe sheath 670 to aid in advancing the sheath over the guide wire 150.At this stage, the distal end of the sheath 670 may be positionedadjacent to the left renal artery 666. A wire guide 672 may beintroduced via the sheath 670. The wire guide 672 may be advanced withinthe sheath 670, within the prosthesis 200, and out the firstfenestration 210 to exit the sheath 670 and enter the left renal artery666 as shown in FIG. 20. The wire guide 672 may be received within acatheter 674, which may be introduced with the wire guide 672 via thesheath 670. The catheter 674 may aid in guiding the wire guide 672 intothe left renal artery 666. To that end, the catheter 674 may be advancedsuch that the distal end of the catheter 674 is positioned near theostium of the left renal artery 666 as shown in FIG. 20. The wire guide672 and the catheter 674 may be further advanced into the left renalartery 666.

The wire guide 672 may be retracted proximally relative to the catheter674 and the sheath 670 to remove the wire guide 672 from the patient'sbody. A wire guide 676 may be introduced through the catheter 674 andthe sheath 670 in a distal direction and ultimately into the left renalartery 666 as shown in FIG. 21. In other words, the wire guide 672 maybe replaced with the wire guide 676. The wire guide 676 may have astiffness that is greater than a stiffness of the wire guide 672. Therelatively stiff wire guide 676 may aid in deploying a branch prosthesisin the first fenestration 210 as further described below.

In a next stage, the sequence shown in FIGS. 19-21 may be repeated tocannulate the right renal artery 668 as shown in FIG. 22. A sheath maybe guided over the second end segment 154 of the guide wire 150 andthrough the second fenestration 220. For example, a sheath 680 may beadvanced over the second end segment 154 of the guide wire 150 in adistal direction, through the lumen 204 of the prosthesis 200, and outthrough the second fenestration 220. A dilator may be positioned withinthe sheath 680 to aid in advancing the sheath over the guide wire 150.At this stage, the distal end of the sheath 680 may be positionedadjacent to the right renal artery 668. A first wire guide (not shown)may be introduced via the sheath 680 and advanced within the sheath 680,within the prosthesis 200, and out the second fenestration 220 to exitthe sheath 680 and enter the right renal artery 668. The first wireguide may be received within a catheter 684, which may be introducedwith the first wire guide via the sheath 680. The first wire guide andthe catheter 684 may be further advanced into the right renal artery668. The first wire guide may be replaced with a wire guide 686, whichmay have a stiffness that is greater than a stiffness of the first wireguide. The relatively stiff wire guide 686 may aid in deploying a branchprosthesis in the second fenestration 220 as further described below.

The position of the first end segment 152 of the guide wire 150 in thefirst fenestration 210 may aid in cannulation of the left renal artery666. Similarly, the position of the second end segment 154 of the guidewire 150 in the second fenestration 220 may aid in cannulation of theright renal artery 668. For example, the first and second end segments152, 154 of the guide wire 150 may extend to the proximal end of theintroducer, and the intermediate segment 156 may be attached to thetubular body 201 of the prosthesis to provide stability to the guidewire and/or the prosthesis during introduction or movement of variouscomponents (e.g., sheaths, wire guides, or catheters) as describedherein. In other words, the guide wire 150 may provide a relativelystable platform for the introduction of various components within thefenestrations of the prosthesis 200. With the catheter 674 and the wireguide 676 in place within the left renal artery 666 and the catheter 684and the wire guide 686 in place within the right renal artery 668, theguide wire 150 may be removed from the patient's body. One of the firstend segment 152 and the second end segment 154 of the guide wire 150 maybe retracted proximally relative to the prosthesis 200 to slide theguide wire out of engagement with the sutures 158 (or other mechanismwhich may secure the guide wire to the tubular body 201). The respectiveend segment may be retracted a sufficient distance to remove the guidewire 150 from the patient's body.

In a next stage, the sheath 670 may be advanced distally over thecatheter 674 and the wire guide 676 and into the left renal artery 666as shown in FIG. 23. With the sheath 670 in place within the left renalartery 666, the catheter 674 may be retracted proximally relative to thesheath 670 and removed from the patient's body. The wire guide 676 mayremain in place within the left renal artery 666. The position of thesheath 670 and the wire guide 676 in the left renal artery 666 mayenable delivery of a branch prosthesis into the left renal artery usingany suitable endovascular technique.

In a next stage, a branch prosthesis 690 may be deployed in the leftrenal artery 666. The branch prosthesis 690 (and the branch prostheses692, 694, 696 described below) may be formed of biocompatible materialsand may be configured as covered stents. Alternatively, the branchprostheses may be configured as bare stents. The covered or bare stentsmay be either self-expanding or balloon expandable. In one embodiment, abranch prosthesis may have both self-expanding and balloon expandablecomponents. The branch prosthesis 690 may be compressed into a deliverystate and delivered using a suitable deployment system or introducer(e.g., the interventional catheters 98A, 98B described above withreference to FIG. 12). For example, an introducer 678 may include adelivery catheter and an outer sheath. In another example, the outersheath may be omitted from the introducer. The branch prosthesis 690 maybe radially compressed onto the delivery catheter of the introducer andcovered by the outer sheath. The introducer 678 may be introduced overthe wire guide 676 and through the sheath 670 in a distal direction fromthe femoral artery and ultimately into the left renal artery 666 asshown in FIG. 23. With the introducer 678 in place within the left renalartery 666, the sheath 670 may be retracted proximally relative to theintroducer 678 and removed from the left renal artery. The branchprosthesis 690 may be deployed from the introducer 678. Upon deployment,the branch prosthesis 690 may extend from the first fenestration 210into the left renal artery 666 as shown in FIG. 24. Upon deployment, thebranch prosthesis 690 and the first fenestration 210 may be mated.Optionally, the devices may be expanded for about 30 seconds using asuitably sized balloon dilation catheter. At this time, the branchprosthesis 690 may provide patent fluid flow through the prosthesis 200into the left renal artery 666. The introducer 678, the wire guide 676,and the sheath 670 then may be withdrawn proximally out of the patient'sbody via the femoral artery.

The branch prosthesis 692 may be deployed in the right renal artery 668in a similar manner. For example, the branch prosthesis 692 may beradially compressed onto a delivery catheter of an introducer, which maybe configured as described above with reference to the introducer 678.The introducer may be introduced over the wire guide 686 and through thesheath 680 in a distal direction from the femoral artery and ultimatelyinto the right renal artery 668. With the introducer in place within theright renal artery 668, the sheath 680 may be retracted proximallyrelative to the introducer and removed from the right renal artery. Thebranch prosthesis 692 may be deployed from the introducer. Upondeployment, the branch prosthesis 692 may extend from the secondfenestration 220 into the right renal artery 668 as shown in FIG. 24.Upon deployment, the branch prosthesis 692 and the second fenestration220 may be mated. Optionally, the devices may be expanded for about 30seconds using a suitably sized balloon dilation catheter. At this time,the branch prosthesis 692 may provide patent fluid flow through theprosthesis 200 into the right renal artery 668. The introducer, the wireguide 686, and the sheath 680 then may be withdrawn proximally out ofthe patient's body via the femoral artery.

The branch prosthesis 694 may be deployed in the celiac artery 662, andthe branch prosthesis 696 may be deployed in the superior mesentericartery 664 using any suitable endovascular technique. Upon deployment,the branch prosthesis 694 may extend from the first branch 231 into theceliac artery 662, and the branch prosthesis 696 may extend from thesecond branch 241 into the superior mesenteric artery 664 as shown inFIG. 24.

The branch prostheses described herein may be deployed in any order. Forexample, the branch prosthesis 690 may be deployed in the left renalartery 666 prior to deployment of the branch prosthesis 692 in the rightrenal artery 668, or vice versa. The branch prostheses 694, 696 may bedeployed in the celiac artery 662 and the superior mesenteric artery664, respectively, before, after, or at approximately the same time asdeployment of the branch prostheses 690, 692 in the left renal artery666 and the right renal artery 668, respectively.

It will be appreciated that the exact number, orientation, and placementof the various branches and/or fenestrations along the tubular body ofthe prosthesis may be varied without departing from the spirit of thisdisclosure. Moreover, while one exemplary procedure has been describedwith reference to the abdominal aorta and its branches, a prosthesishaving multiple branches and/or fenestrations as described herein may beused in other procedures, and particularly those that may benefit from apreloaded arrangement to facilitate insertion of delivery componentsinto the various openings of the prosthesis.

FIG. 25 illustrates another example of the guide wire 150 receivedwithin the prosthesis 200 in a preloaded configuration. In this example,the prosthesis 200 may be substantially free of guide wire openings asdescribed above with reference to FIG. 17. The first end segment 152 ofthe guide wire 150 may extend distally from the proximal end of thedelivery device. The first end segment 152 may enter the lumen 204through the proximal end 202 of the prosthesis 200. The first endsegment 152 may extend distally within the lumen 204 and exit thetubular body 201 of the prosthesis 200 through the first fenestration210.

The intermediate segment 156 of the guide wire 150 may extend betweenthe first fenestration 210 and the second fenestration 220 of theprosthesis 200. The intermediate segment 156 may extend distallyexternal of the tubular body 201 toward the first branch 231. Theintermediate segment 156 may enter the lumen 234 of the first branch 231at the second end 233, extend distally within the first branch, andenter the lumen 204 through the third fenestration 230. The intermediatesegment may enter the lumen 244 of the second branch 241 through thefourth fenestration 240, extend proximally within the second branch, andexit the second branch at the second end 243. The intermediate segment156 may extend proximally external of the tubular body 201 toward thesecond fenestration 220.

The second end segment 154 of the guide wire 150 may enter the tubularbody 201 of the prosthesis 200 through the second fenestration 220. Thesecond end segment 154 may extend proximally within the lumen 204 andexit the lumen 204 through the proximal end 202 of the prosthesis 200.The second end segment 154 of the guide wire 150 may extend proximallyto the proximal end of the delivery device. The first end segment 152 ofthe guide wire 150 may enable introduction of a branch prosthesis intoeach of the first fenestration 210 and the second branch 241 to couplethe prosthesis 200 to the left renal artery and the superior mesentericartery, and the second end segment 154 of the guide wire 150 may enableintroduction of a branch prosthesis into each of the second fenestration220 and the first branch 231 to couple the prosthesis to the right renalartery and the celiac artery as further described below.

The intermediate segment 156 of the guide wire 150 may be substantiallyU-shaped with the opening of the U-shaped intermediate segment facingproximally as shown in FIG. 25. One leg of the U-shaped intermediatesegment 156 may extend distally away from the first fenestration 210 andthrough the first branch 231 and the third fenestration 230. The otherleg may extend proximally through the fourth fenestration 240 and thesecond branch 241 and toward the second fenestration 220. The curvedportion of the U-shaped intermediate segment 156 may be positionedwithin the lumen 204 as shown in FIG. 25. Additionally, oralternatively, the curved portion of the U-shaped intermediate segment156 may be positioned longitudinally distal of the third and fourthfenestrations 230, 240 and proximal of the distal end 203 of theprosthesis 200. Additionally, or alternatively, the guide wire 150 maybe positioned such that no portion of the guide wire extends distallybeyond the distal end 203 of the prosthesis 200.

FIGS. 26-31 illustrate an exemplary method of using the prosthesis 200of FIG. 25 to treat a condition (e.g., an aneurysm) in the area of anabdominal aorta and/or branch vessels of a patient. In a first step, theprosthesis 200 may be provided with the guide wire 150 coupled to theprosthesis in the preloaded configuration as shown in FIG. 25. Theprosthesis 200 may be compressed into a delivery state and deliveredinto the abdominal aorta 660 of a patient using any suitable deploymentsystem or introducer (e.g., the delivery catheter 1 described above withreference to FIGS. 1-12) as described above with reference to FIG. 18.

With the prosthesis 200 positioned within the abdominal aorta 660, eachof the left renal artery 666, the right renal artery 668, the celiacartery 662, and the superior mesenteric artery 664 may be cannulated. Tothat end, the sheath 670 may be advanced over the second end segment 154of the guide wire 150 in a distal direction as shown in FIG. 26. Thesheath 670 may be advanced distally through the lumen 204 of theprosthesis 200 and out through the second fenestration 220. The sheath670 may be further advanced distally through the lumen 244 of the secondbranch 241 and the fourth fenestration 240 into the lumen 204 of theprosthesis 200. The sheath 670 may be further advanced over the curvedportion of the intermediate segment 156 of the guide wire 150 andproximally through the third fenestration 230 and the lumen 234 of thefirst branch 231. The sheath 670 may exit the first branch 231 throughthe second end 233 as shown in FIG. 26. At this stage, the distal end ofthe sheath 670 may be positioned adjacent to the celiac artery 662.

The wire guide 672 may be introduced via the sheath 670. The wire guide672 may be advanced within the sheath 670 until the distal end of thewire guide 672 exits the sheath 670 and enters the celiac artery 662 asshown in FIG. 26. In this manner, the preloaded wire guide 150 may beused to cannulate the celiac artery 662 with the wire guide 672. Thewire guide 672 may be received within a catheter as described above withreference to FIG. 20. The wire guide 672 may be replaced with therelatively stiffer wire guide 676A as described above with reference toFIGS. 20-21 to aid in deploying a branch prosthesis in the first branch231 as further described below.

The sheath 670 may be retracted over the guide wire 150. For example,the proximal end of the sheath 670 may be retracted proximally over thesecond end segment 154 of the guide wire 150 to retract the distal endof the sheath distally through the first branch 231 and the thirdfenestration 230, over the curved portion of the intermediate segment ofthe guide wire 150, and proximally through the fourth fenestration 240and the second branch 241. The sheath 670 may be retracted a sufficientdistance such that the distal end of the sheath 670 is positionedadjacent to the right renal artery 668 as shown in FIG. 27.

In a next stage, the sequence described above with reference to FIG. 26may be repeated to cannulate the right renal artery 668. For example,the wire guide 672, or another wire guide, may be introduced via thesheath 670 and advanced within the sheath 670, within the prosthesis200, and out the second fenestration 220 to exit the sheath 670 andenter the right renal artery 668 as shown in FIG. 27. The wire guide 672may be received within a catheter as described above with reference toFIG. 20. The wire guide 672 may be replaced with a relatively stifferwire guide 676B to aid in deploying a branch prosthesis in the secondfenestration 220 as further described below. With each of the celiacartery 662 and the right renal artery 668 cannulated as shown in FIG.28, the sheath 670 may be retracted proximally over the second endsegment 154 of the guide wire 150 and removed from the patient's body.

In a next stage, the sheath 670, or another sheath, may be advanced overthe first end segment 152 of the guide wire 150 in a distal direction asshown in FIG. 29. The sheath 670 may be advanced distally through thelumen 204 of the prosthesis 200 and out through the first fenestration210. The sheath 670 may be further advanced distally through the lumen234 of the first branch 231 and the third fenestration 230 into thelumen 204 of the prosthesis 200. The sheath 670 may be further advancedover the curved portion of the intermediate segment 156 of the guidewire 150 and proximally through the fourth fenestration 240 and thelumen 244 of the second branch 241. The sheath 670 may exit the secondbranch 241 through the second end 243 as shown in FIG. 29. At thisstage, the distal end of the sheath 670 may be positioned adjacent tothe superior mesenteric artery 664.

The wire guide 672, or another wire guide, may be introduced via thesheath 670. The wire guide 672 may be advanced within the sheath 670until the distal end of the wire guide 672 exits the sheath 670 andenters the superior mesenteric artery 664 as shown in FIG. 29. In thismanner, the preloaded guide wire 150 may be used to cannulate thesuperior mesenteric artery 664 with the wire guide 672. The wire guide672 may be received within a catheter as described above with referenceto FIG. 20. The wire guide 672 may be replaced with the relativelystiffer wire guide 676C as described above with reference to FIGS. 20-21to aid in deploying a branch prosthesis in the second branch 241 asfurther described below.

The sheath 670 may be retracted over the guide wire 150. For example,the proximal end of the sheath 670 may be retracted proximally over thefirst end segment 152 of the guide wire 150 to retract the distal end ofthe sheath distally through the second branch 241 and the fourthfenestration 240, over the curved portion of the intermediate segment ofthe guide wire 150, and proximally through the third fenestration 230and the first branch 231. The sheath 670 may be retracted a sufficientdistance such that the distal end of the sheath 670 is positionedadjacent to the left renal artery 666 as shown in FIG. 30.

In a next stage, the sequence described above with reference to FIG. 26may be repeated to cannulate the left renal artery 666 as shown in FIG.30. For example, the wire guide 672, or another wire guide, may beintroduced via the sheath 670 and advanced within the sheath 670, withinthe prosthesis 200, and out the first fenestration 210 to exit thesheath 670 and enter the left renal artery 666. The wire guide 672 maybe received within a catheter as described above with reference to FIG.20. The wire guide 672 may be replaced with a relatively stiffer wireguide 676D to aid in deploying a branch prosthesis in the firstfenestration 210 as further described below. With each of the superiormesenteric artery 664 and the left renal artery 666 cannulated, thesheath 670 may be retracted proximally over the first end segment 152 ofthe guide wire 150 and removed from the patient's body. At this stage,the prosthesis 200 may be deployed within the aorta 660 with each of theceliac artery 662, the superior mesenteric artery 664, the left renalartery 666, and the right renal artery 668 cannulated with a respectivewire guide as shown in FIG. 31.

Following cannulation of the branch vessels, the guide wire 150 may beremoved from the patient's body. For example, one of the first endsegment 152 and the second end segment 154 of the guide wire 150 may beretracted proximally relative to the prosthesis 200 to slide the guidewire out of engagement with the first and second branches 231, 241 andthe first and second fenestrations 210, 220. The respective end segmentmay be retracted a sufficient distance to remove the guide wire 150 fromthe patient's body.

A branch prosthesis may be deployed within each of the celiac artery662, the superior mesenteric artery 664, the left renal artery 666, andthe right renal artery 668 using any suitable endovascular technique asdescribed above with reference to FIGS. 23-24. For example, a deliverydevice may be introduced over the wire guide 676A and used to deploy thebranch prosthesis 694 into the celiac artery 662, a delivery device maybe introduced over the wire guide 676B and used to deploy the branchprosthesis 692 into the right renal artery 668, a delivery device may beintroduced over the wire guide 676C and used to deploy the branchprosthesis 696 into the superior mesenteric artery 664, and a deliverydevice may be introduced over the wire guide 676D and used to deploy thebranch prosthesis 690 into the left renal artery 666. In this manner,the first branch 231 may be mated to the celiac artery 662 with thebranch prosthesis 694, the second fenestration 220 may be mated to theright renal artery 668 with the branch prosthesis 692, the second branch241 may be mated to the superior mesenteric artery 664 with the branchprosthesis 696, and the first fenestration 210 may be mated to the leftrenal artery 666 with the branch prosthesis 690 as shown in FIG. 24. Thebranch prostheses may be deployed within the respective branch vesselsin any order.

The configuration of the preloaded guide wire 150 may enable cannulationof each of the celiac artery 662, the superior mesenteric artery 664,the left renal artery 666, and the right renal artery 668 from a singleaccess point (e.g., from a single incision into a single femoralartery). This may enable the prosthesis 200 to be deployed in a shorteramount of time than may be required using multiple access points (e.g.,two femoral arteries, a femoral artery and a brachial artery, or anyother multiple access points). Additionally, or alternatively, theconfiguration of the preloaded guide wire 150 may enable cannulation ofmultiple vessels simultaneously. For example, once the celiac artery 662has been cannulated and the sheath 670 has been retracted to align withthe right renal artery 668 as shown in FIG. 27, the right renal arterymay be cannulated while another sheath is advanced over the first end152 of the guide wire 150 to cannulate the superior mesenteric artery696. In this manner, once one of the first and second branches 231, 241of the prosthesis 200 has been cannulated, the other branch may becannulated (e.g., by a second operator) while one of the first andsecond fenestrations 210, 220 is being cannulated. This may reduce theamount of time required to deploy the prosthesis 200.

While various embodiments of the invention have been described, theinvention is not to be restricted except in light of the attached claimsand their equivalents. Moreover, the advantages described herein are notnecessarily the only advantages of the invention and it is notnecessarily expected that every embodiment of the invention will achieveall of the advantages described.

We claim:
 1. A system comprising: an endoluminal prosthesis comprising atubular body comprising a graft material wall, a proximal end opening, adistal end opening, and a lumen extending longitudinally therein; afirst fenestration in the graft material wall, a second fenestration inthe graft material wall circumferentially offset from the firstfenestration, a third fenestration in the graft material wall distal ofthe first and second fenestrations, a fourth fenestration in the graftmaterial wall distal of the first and second fenestrations andcircumferentially offset from the third fenestration, a first branchextending from the third fenestration and having an open end, a secondbranch extending from the fourth fenestration and having an open end;and a guide preloaded in the tubular body and having a first end and asecond end both extending from a region proximal of the proximal endopening of the tubular body, the guide entering the proximal endopening, exiting the first fenestration, partially longitudinallytraversing an exterior surface of the prosthesis in a distal directionto the first branch, entering the open end of the first branch, enteringthe third fenestration into the tubular body lumen, partially laterallytraversing an interior surface of the prosthesis to the fourthfenestration, exiting the fourth fenestration into the second branch,extending through the second branch, exiting the second branch endopening, partially longitudinally traversing the exterior surface of theprosthesis in a proximal direction to the second fenestration, enteringthe second fenestration into the lumen of the tubular body, and exitingthe proximal end opening of the prosthesis.
 2. The system of claim 1,wherein the guide traverses the interior surface of the prosthesis abovethe third and fourth fenestrations.
 3. The system of claim 1, whereinthe guide traverses the interior surface of the prosthesis substantiallybetween the third and fourth fenestrations.
 4. The system of claim 1,wherein the guide is a guidewire.
 5. The system of claim 1, wherein theguide is an indwelling catheter configured to receive a guidewire. 6.The system of claim 1, wherein a portion of the guide that laterallytraverses the interior surface is secured to the interior surface. 7.The system of claim 1, further comprising a fifth fenestration in thegraft material wall disposed distally of the first and secondfenestrations.
 8. The system of claim 1, further comprising a scallop atthe distal end opening.
 9. A system comprising: an endoluminalprosthesis comprising a tubular body comprising a graft material wall, aproximal end opening, a distal end opening, and a lumen extendinglongitudinally therein; a first fenestration in the graft material wall,a second fenestration in the graft material wall, a first branchpositioned distally of the first fenestration, and a second branchpositioned distally of the second fenestration, the first fenestrationand the second fenestration spaced from one another circumferentiallyabout the tubular body, and the first branch and the second branchspaced from one another circumferentially about the tubular body; and aguide wire having a first end and a second end both extending from aregion proximal of the proximal end opening of the tubular body, theguide wire entering the proximal end opening, exiting the firstfenestration, partially longitudinally traversing an exterior surface ofthe prosthesis in a distal direction to the first branch, entering thefirst branch, partially laterally traversing an interior surface of theprosthesis to the second branch, exiting the second branch, partiallylongitudinally traversing the exterior surface of the prosthesis in aproximal direction to the second fenestration, entering the secondfenestration, and exiting the proximal end opening of the prosthesis,wherein at least one of the first and second fenestrations is pivotableand are configured to pivot relative to the tubular body.
 10. The systemof claim 9, further including a third fenestration, wherein the firstand second fenestrations are pivotable, and the third fenestration innonpivotable.
 11. The system of claim 9, wherein a portion of the guidewire that partially laterally traverses the interior surface of theprosthesis is attached to the interior surface of the prosthesis. 12.The system of claim 9, wherein the pivotable fenestration has an innerperimeter surrounding the fenestration, a band of material surroundingthe inner perimeter, and an outer perimeter surrounding the band ofmaterial, such that the fenestration, the inner perimeter, the band ofmaterial and the outer perimeter are all concentric.
 13. The system ofclaim 12, wherein the inner perimeter, the band of material and theouter perimeter form an extension have a substantially dome shape. 14.The system of claim 13, wherein the pivotable fenestration has a concaveorientation and a convex orientation and is configured to pivot betweenthe concave and convex orientations.
 15. The system of claim 9, whereinone or both of the first and second branches are configured to receivebranch extensions.
 16. A system comprising: an endoluminal prosthesiscomprising a tubular body comprising a graft material wall, a proximalend opening, a distal end opening, and a lumen extending longitudinallytherein; a first fenestration in the graft material wall, a secondfenestration in the graft material wall, the first fenestration and thesecond fenestration spaced from one another circumferentially about thetubular body, a third fenestration in the graft material wall distallyof the first and second fenestrations, and a fourth fenestration in thegraft material wall distally of the first and second fenestrations, afirst branch extending from the third fenestration and a second branchextending from the fourth fenestration; and a guide wire having a firstend and a second end both extending from a region proximal of theproximal end opening, the guide wire entering the proximal end opening,exiting the first fenestration, partially longitudinally traversing anexterior surface of the prosthesis to the second fenestration, enteringthe second fenestration, and exiting the proximal end opening of theprosthesis.
 17. The system of claim 16, wherein at least the first andsecond fenestrations are configured to receive branch prostheses. 18.The system of claim 17, wherein the first and second branches areconfigured to receive branch prostheses.